Phytochemical, Vitamin, and Actives testing

This assay quantifies a full panel of creatine-related compounds to confirm potency, and identity. It includes analysis of Creatine Monohydrate, Creatine, Creatinine, Dicyandiamide, and Creatine Nitrate, providing a comprehensive profile for raw materials and finished supplements.

The sample is weighed and dissolved following USP guidelines. Using either HPLC or titrimetric analysis, creatine is quantified by comparing the sample response to a certified reference standard. Moisture content is corrected for, and duplicate analyses along with system suitability tests are performed to ensure accuracy.

Results are expressed as a percentage (on a dried basis) or in mg per serving. Values within the USP-specified range indicate that the product meets purity and dosage requirements, while deviations may signal formulation or processing issues.

This assay measures crocin, a carotenoid glycoside, using High-Performance Liquid Chromatography with UV-Visible detection (HPLC/UV-Vis). The analysis provides accurate quantification for quality control and standardization.

Samples are extracted and analyzed under validated HPLC conditions. Crocin is chromatographically separated and detected by UV-Vis at its characteristic absorbance. Quantitation is performed using certified reference standards, with calibration curves and replicate injections ensuring accuracy and reproducibility.

Testing verifies standardized potency, confirms label claims, and ensures batch-to-batch consistency.

This test quantifies crocins — the water-soluble carotenoid glycosides responsible for saffron's characteristic deep red color and primary bioactivity — in saffron (Crocus sativus) raw materials, standardized extracts, and dietary supplements using High-Performance Liquid Chromatography with UV-Visible (HPLC/UV-Vis) detection. Crocins, principally trans-crocetin di-(β-D-gentiobiosyl) ester (crocin-1) and its related esters, are the key marker compounds used to standardize saffron extracts and are directly linked to the ingredient's documented effects on mood, cognitive function, and antioxidant capacity. Accurate quantification confirms extract potency, supports label claim substantiation, and helps detect adulteration with synthetic colorants or inferior saffron materials. Results are reported as a percentage or in milligrams per gram.

A representative sample is accurately weighed and extracted using aqueous methanol or water, with sonication to ensure complete dissolution of the polar crocin glycosides. The extract is filtered through a 0.2 µm membrane and analyzed by reversed-phase HPLC on a C18 column, with UV-Vis detection at approximately 440 nm — the characteristic absorption maximum of the crocin chromophore. Individual crocin esters (crocin-1 through crocin-4) are resolved chromatographically and quantified against a multi-point external calibration curve prepared from a certified crocin reference standard. Safranal and picrocrocin peaks may also be monitored concurrently to provide a comprehensive saffron quality profile. System suitability and quality control standards are run at regular intervals to confirm method accuracy and precision.

Saffron is the world's most expensive spice by weight and is one of the most heavily adulterated botanical ingredients in the supplement industry, with common adulterants including synthetic carotenoid dyes (e.g., Sudan red, tartrazine), safflower petals, and low-grade saffron stigmas mixed with styles. HPLC/UV-Vis quantification of individual crocin esters provides a highly specific and reproducible measure of saffron extract potency that cannot be replicated by simple UV absorbance measurements alone, enabling detection of adulteration with non-saffron colorants that may absorb at similar wavelengths. This test is aligned with ISO 3632 quality standards for saffron and supports both raw material qualification and finished product release under 21 CFR 111.

This assay estimates crude fiber by measuring the indigestible residue remaining after sequential acid and alkali digestion of the food sample. It primarily captures components such as cellulose and lignin, though it underestimates total dietary fiber. It is used in legacy analyses and certain feed quality assessments to gauge plant residue content.

The sample is defatted (if necessary) and boiled in dilute acid to remove starches and soluble components, then treated with dilute alkali. The residue is filtered, dried, and weighed, and subsequently incinerated to determine ash content. The difference between the dry residue and ash weight provides the crude fiber content, with replicate testing and blanks ensuring method consistency.

Results are given as a percentage of the sample weight. Higher crude fiber values indicate a greater proportion of indigestible plant material. Although it does not capture all fiber, it provides a comparative metric for consistency across batches or ingredients.

This assay quantifies curcuminoid content in turmeric (Curcuma longa) extracts using HPLC. It measures four key bioactive compounds: Total Curcuminoids, Bisdemethoxycurcumin, Curcumin, and Demethoxycurcumin. This profile is essential for verifying potency, ensuring extract standardization (e.g., 95% curcuminoids), and detecting adulteration or degradation.

Samples are extracted using solvents optimized for curcuminoid recovery under light-protected conditions. The extract is analyzed by HPLC with detection at a specific wavelength for curcumin and its analogs (demethoxycurcumin and bisdemethoxycurcumin). Calibration with high-purity curcumin standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in mg per g or per serving. The values are assessed against label claims and formulation targets. Measuring curcumin content confirms extract standardization and helps ensure therapeutic consistency across production batches.

This assay quantifies total curcuminoids in turmeric (Curcuma longa) extracts using HPLC. It measures the key bioactive compounds which are responsible for turmeric’s functional properties. This profile is essential for verifying standardized extracts (e.g., 95% curcuminoids) and ensuring potency in finished products.

Samples are extracted using methanol or other suitable organic solvents and analyzed by HPLC with UV detection (typically at ~425 nm). Quantification is performed using certified reference standards for each curcuminoid, with internal standard correction and duplicate injections for precision.

Results are reported in mg per g or % w/w for each compound and total curcuminoids. Values are compared to formulation targets and label claims to confirm potency, detect degradation, and identify possible adulteration.

This test confirms the identity of dandelion root (Taraxacum officinale F.H. Wigg., and related Taraxacum species) in raw materials, root powders, extracts, and dietary supplements using High-Performance Thin-Layer Chromatography (HPTLC). Taraxacum officinale, commonly known as dandelion, is a widely used medicinal plant with a long history of use in traditional Western herbal medicine for supporting liver and gallbladder function, digestive health, and as a mild diuretic. Its characteristic phytochemical profile includes sesquiterpene lactones (taraxacin, taraxacerin), triterpenoids (taraxasterol, β-amyrin), phenolic acids (chicoric acid, chlorogenic acid), flavonoids (luteolin glycosides), and inulin-type fructooligosaccharides. HPTLC identity testing generates a characteristic chromatographic fingerprint that is compared against an authenticated T. officinale reference standard to confirm species identity and detect potential adulteration, substitution with other Taraxacum species or related Asteraceae family members, or blending with unrelated plant materials.

A representative sample is accurately weighed and extracted using an appropriate solvent system (e.g., methanol or aqueous ethanol) to capture the characteristic secondary metabolite profile of T. officinale root, including sesquiterpene lactones, triterpenoids, and phenolic acids. The extract is applied alongside a certified dandelion root reference standard and, where applicable, potential adulterant extracts, onto an HPTLC silica gel plate using an automated sample applicator. The plate is developed in a validated solvent system optimized to resolve the characteristic marker compounds of T. officinale root. After development, the plate is derivatized with an appropriate reagent (e.g., anisaldehyde-sulfuric acid or Natural Products Reagent A / NP/PEG for phenolic and flavonoid visualization) and evaluated under white light and UV light at 254 nm and 366 nm. The resulting fingerprint pattern is compared visually and, where applicable, by densitometric analysis to the authenticated reference standard in accordance with established HPTLC identity testing guidelines.

Dandelion root raw materials are subject to adulteration and species substitution, including replacement with other Taraxacum species, related Asteraceae members, or unrelated root materials that may share morphological similarities in dried and powdered form. HPTLC fingerprinting provides a holistic, multi-compound chromatographic identity confirmation that is more discriminating than single-marker assays, enabling detection of substitution or adulteration that would not be apparent from potency testing alone. This method aligns with USP botanical identity testing guidelines and supports cGMP compliance under 21 CFR 111, ensuring that only correctly identified raw materials are used in finished products.

This assay measures D-Chiro Inositol (DCI), one of the biologically active inositol isomers involved in insulin signaling and ovarian function. LC-MS/MS provides high sensitivity and selectivity for distinguishing DCI from other inositol forms in complex formulations.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. D-Chiro Inositol is detected in multiple reaction monitoring (MRM) mode and quantified using certified reference standards. Internal calibration and quality control checks ensure precision and reproducibility.

Testing confirms label accuracy, supports standardized dosing, and ensures product consistency—especially when products also contain Myo-Inositol.

This assay quantifies dehydroepiandrosterone (DHEA), a steroid hormone precursor to androgens and estrogens. Using HPLC, it verifies DHEA content in dietary supplements and raw materials to ensure label accuracy, potency, and stability across production batches.

Samples are extracted in organic solvents and analyzed by HPLC with UV detection at a compound-specific wavelength. Quantification is performed using certified DHEA reference standards, with internal standard correction and duplicate injections to ensure reproducibility and accuracy.

Results are reported in mg per g or per serving. Values are compared to declared label claims and formulation targets to confirm dosing consistency and detect underformulation or degradation.

This test quantifies desmosine — a pyridinium-based crosslink amino acid found exclusively in mature elastin — in dietary supplements, protein hydrolysates, and raw materials using LC-MS/MS. Because desmosine is biosynthetically unique to elastin and is not present in any other protein, its quantification serves as a highly specific and definitive marker for true elastin content. This test is particularly valuable for verifying elastin-containing ingredients and distinguishing genuine elastin hydrolysates from collagen or gelatin substitutes. Results are reported in micrograms per gram or per serving.

A representative sample is acid-hydrolyzed (typically with 6N hydrochloric acid at elevated temperature) to release desmosine from its crosslinked protein matrix. The hydrolysate is neutralized, filtered, and spiked with an isotopically labeled desmosine internal standard. The sample is analyzed by reversed-phase LC-MS/MS with ESI in positive ion mode, using MRM transitions specific to desmosine. Quantification is performed against a multi-point external calibration curve prepared from a certified desmosine reference standard. Quality control samples and method blanks are run concurrently to confirm accuracy, precision, and absence of contamination.

Desmosine is the only amino acid known to be exclusive to elastin, making it the gold-standard biochemical marker for confirming the presence and quantity of true elastin in a sample. LC-MS/MS with MRM detection provides the sensitivity and specificity required to quantify desmosine at the low concentrations present in hydrolyzed elastin preparations, and its exclusive origin in elastin eliminates the ambiguity associated with non-specific protein quantification methods. This test is essential for authenticating elastin ingredients and substantiating label claims.

This assay quantifies dietary fiber using AOAC 2001.03 with AOAC 991.43 enzymatic digestion. The method measures total dietary fiber and differentiates soluble and insoluble fractions, including resistant FOS that are not digested in the small intestine.

Samples undergo enzymatic digestion per AOAC 991.43 to simulate human digestion, followed by gravimetric and chromatographic determination according to AOAC 2001.03. Soluble and insoluble fiber fractions are isolated and quantified, then combined to calculate total dietary fiber. Quality controls and method blanks ensure accuracy and reproducibility.

Testing verifies nutrition facts labeling, supports fiber-related claims, and ensures compliance with FDA and international dietary fiber definitions.

This assay quantifies total dietary fiber—including both soluble and insoluble fractions—in food samples. It mimics human digestion by enzymatically removing starch and protein, leaving behind fiber fractions that are then separated and measured. This method provides a comprehensive fiber profile for nutritional labeling and product formulation.

The sample is treated sequentially with α‑amylase, protease, and amyloglucosidase to remove digestible components. Insoluble fiber is collected by filtration, while soluble fiber is precipitated with ethanol. Both fractions are washed, dried, and weighed, then corrected for residual protein and ash content. Calibration and duplicate tests ensure robustness.

Results are reported as grams of fiber per 100 g of product (or as a percentage), and may be divided into soluble and insoluble fractions. Consistent fiber values support nutritional claims, while variations may indicate changes in formulation or processing efficiency.

This test quantifies dihydroberberine, a hydrogenated form of berberine with improved bioavailability, using High-Performance Liquid Chromatography (HPLC). It is applicable to raw botanical materials and finished dietary supplements such as capsules and powders. The method provides precise measurement down to 0.1% w/w, ensuring product consistency and label accuracy.

Samples are prepared by extracting 0.5 g of material with methanol using sonication for 30 minutes, followed by filtration. The extract is injected into an HPLC system equipped with a C18 column and UV detection at 345 nm. Separation of dihydroberberine from berberine and other alkaloids is achieved using a gradient mobile phase of water and acetonitrile with 0.1% formic acid. Quantification is performed against a certified dihydroberberine reference standard using a five-point calibration curve. Method precision is verified through duplicate injections and spike recovery tests at multiple concentration levels.

Testing confirms label claims, verifies ingredient purity, and ensures consistency across metabolic-support formulations.

This test quantifies dihydromyricetin (DHM), a bioactive flavonoid known for its antioxidant properties, in raw materials and finished botanical products such as powders and capsules. The assay employs High-Performance Liquid Chromatography (HPLC) with UV detection to provide precise measurement of DHM content, reported in mg per gram of sample. Accurate DHM quantification supports quality control and standardization of botanical ingredients and supplements.

Samples are prepared by extracting 0.5 g of powdered material with 10 mL of 70% methanol using sonication for 30 minutes, followed by filtration. The extract is injected into an HPLC system equipped with a C18 reversed-phase column and UV detection set at 290 nm. Separation is achieved using a gradient elution of water and acetonitrile with 0.1% formic acid over 30 minutes. Quantification is performed using an external calibration curve constructed from certified DHM reference standards ranging from 1 to 100 µg/mL. Method precision and accuracy are verified through duplicate injections, quality control samples, and spike recovery tests.

Results are reported in mg/g (raw materials) or mg/serving (finished products). Testing verifies standardized potency, confirms product label claims, and ensures consistent quality across botanical and antioxidant formulations.

This test quantifies dihydroquercetin (also known as taxifolin) — a potent bioflavonoid found in sources such as Siberian larch (Larix sibirica), onions, and milk thistle — in raw materials, extracts, and dietary supplements using High-Performance Liquid Chromatography (HPLC). Dihydroquercetin is highly valued for its strong antioxidant capacity and its role in supporting cardiovascular, liver, and immune health. Accurate quantification is essential for verifying the potency of standardized extracts and ensuring that finished products meet their label claims for this specific flavonoid. Results are reported as a percentage or in milligrams per gram or per serving.

A representative sample is accurately weighed and extracted using an appropriate solvent, such as aqueous methanol or ethanol, often utilizing sonication to ensure complete dissolution of the flavonoid content. The extract is filtered and analyzed by reversed-phase HPLC equipped with a UV-Vis or Photodiode Array (PDA) detector, monitoring absorbance at a specific wavelength (typically around 280–290 nm) characteristic of dihydroquercetin. Quantification is performed against a multi-point external calibration curve prepared from a certified dihydroquercetin (taxifolin) reference standard. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

Dihydroquercetin is structurally similar to other flavonoids like quercetin, making specific quantification critical for quality control. HPLC with UV or PDA detection provides the necessary chromatographic resolution to separate dihydroquercetin from related bioflavonoids and complex matrix interferences. This ensures an accurate and specific measurement of the active compound, supporting label claim substantiation, raw material qualification, and cGMP compliance under 21 CFR 111.

This test quantifies diosmin — a naturally occurring flavone glycoside found in citrus fruits and certain other plants, and widely used as a venotonic and vascular-protective ingredient in dietary supplements — in raw materials and finished products using High-Performance Liquid Chromatography (HPLC). Diosmin is commonly used alone or in combination with hesperidin to support venous insufficiency, hemorrhoidal symptoms, and overall vascular health. Accurate potency verification is essential for confirming that the declared amount of this active flavonoid is present and that the product meets its quality specification. Results are reported as a percentage or in milligrams per gram or per serving.

A representative sample is accurately weighed and extracted using aqueous methanol or dimethyl sulfoxide (DMSO) with sonication to ensure complete dissolution of the poorly water-soluble flavonoid. The extract is filtered through a 0.2 µm membrane and analyzed by reversed-phase HPLC on a C18 column, with UV or Photodiode Array (PDA) detection at approximately 268–270 nm. Quantification is performed against a multi-point external calibration curve prepared from a certified diosmin reference standard. Peak identity is confirmed by retention time and UV spectral comparison to the reference standard, and the method resolves diosmin from its structurally related aglycone diosmetin and from hesperidin, which may be present in citrus-derived materials. System suitability and quality control standards are run concurrently to confirm method accuracy and precision.

Diosmin is frequently formulated alongside hesperidin in fixed-ratio combination products, and HPLC provides the chromatographic resolution needed to individually quantify each flavonoid and confirm that the declared ratio and individual potencies are accurate. As a semi-synthetic ingredient derived from hesperidin, diosmin purity and potency can vary between suppliers, making rigorous HPLC testing an important component of raw material qualification. This test supports label claim compliance and cGMP requirements under 21 CFR 111.

This test quantifies diindolylmethane (DIM; 3,3'-diindolylmethane) — a bioactive indole compound formed from the acid-catalyzed condensation of indole-3-carbinol (I3C), itself a glucosinolate hydrolysis product found in cruciferous vegetables such as broccoli, cabbage, and Brussels sprouts — in raw materials, extracts, and dietary supplements using High-Performance Liquid Chromatography (HPLC). DIM is widely used in dietary supplements for its role in supporting estrogen metabolism, hormonal balance, and cellular health. Accurate potency verification is essential for label claim substantiation and for confirming that the declared amount of DIM is present, as DIM content can vary significantly depending on the source material and manufacturing process. Results are reported as a percentage or in milligrams per gram or per serving.

A representative sample is accurately weighed and dissolved in an appropriate organic solvent, typically methanol or acetonitrile, to ensure complete dissolution of DIM, which has limited aqueous solubility. The extract is filtered and analyzed by reversed-phase HPLC on a C18 column with UV detection at 280 nm, the characteristic absorption maximum of the diindolylmethane chromophore. Quantification is performed against a multi-point external calibration curve prepared from a certified DIM reference standard. Where applicable, related indole compounds such as indole-3-carbinol (I3C) may be monitored simultaneously to provide a more complete indole profile. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

DIM's strong UV absorption at 280 nm makes HPLC with UV detection a sensitive and specific method for its quantification in dietary supplement matrices. Chromatographic separation resolves DIM from structurally related indole compounds — including I3C, indole-3-acetonitrile, and other condensation products — that may co-occur in cruciferous-derived extracts, ensuring that potency results reflect DIM content specifically. This specificity is important for label claim accuracy and for confirming that the biologically active DIM form is present rather than precursor compounds. The method supports raw material qualification, finished product release testing, and cGMP compliance under 21 CFR 111.

This test quantifies 2-Dimethylaminoethanol (DMAE), a compound commonly included in cognitive and mood-support supplements, using LC-MS/MS for precise measurement. The method is suitable for raw materials, capsules, and finished products, providing detection limits down to low microgram per gram levels to ensure product consistency and label accuracy.

Samples are prepared by extracting DMAE with an aqueous methanol solution, followed by filtration to remove particulates. Analysis is performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) with detection in multiple reaction monitoring (MRM) mode targeting specific DMAE transitions. Quantification is achieved using a calibration curve constructed from certified DMAE reference standards, with an internal standard added to correct for variability. Method accuracy and precision are verified through duplicate injections, matrix spike recoveries, and inclusion of quality control samples throughout the analytical run.

Testing confirms label claims, ensures purity, and verifies consistent manufacturing quality.

This assay quantifies D-mannose, a naturally occurring sugar used in urinary health supplements and functional products. Using LC-MS/MS, it confirms D-mannose content to support label accuracy, verify dosing, and ensure purity in formulations marketed for bladder and kidney support.

Samples are extracted in water or dilute acid, then analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed using certified D-mannose standards with internal standard correction and duplicate runs to ensure precision and reproducibility.

Results are reported in g per 100 g or per serving. Values are compared to formulation targets and label claims to confirm ingredient integrity and detect adulteration or underdosing.

This test quantifies elastin — a highly cross-linked structural protein responsible for the elasticity and resilience of skin, blood vessels, and connective tissue — in dietary supplements, collagen and protein ingredients, and raw materials using LC-MS/MS. Elastin-derived peptides are increasingly used in beauty-from-within and joint health formulations, and accurate quantification confirms that the declared elastin content is present and verifies the integrity of the protein source. LC-MS/MS enables specific detection of elastin-derived peptide markers in complex protein matrices. Results are reported in milligrams per gram or per serving.

A representative sample is hydrolyzed under controlled conditions to release elastin-specific peptide fragments or crosslink-derived amino acids. The hydrolysate is filtered, diluted in an aqueous solvent, and spiked with an isotopically labeled internal standard. The sample is analyzed by LC-MS/MS using reversed-phase chromatography and electrospray ionization (ESI) in positive ion mode, with MRM transitions selected for elastin-characteristic peptides or marker residues. Quantification is performed against a multi-point external calibration curve prepared from a certified elastin reference standard. Quality control samples are run concurrently to confirm method accuracy and precision.

Elastin is a high-value structural protein ingredient that may be substituted with lower-cost collagen or gelatin hydrolysates in finished products. LC-MS/MS provides the molecular specificity needed to identify and quantify elastin-derived markers in complex protein matrices, distinguishing elastin from other structural proteins and confirming both the identity and potency of the ingredient. This supports label claim accuracy and raw material qualification under 21 CFR 111.

This test confirms the identity of elderberry (Sambucus nigra L.) in raw materials, berry powders, juice powders, extracts, and dietary supplements using High-Performance Thin-Layer Chromatography (HPTLC). Sambucus nigra, commonly known as European elderberry or black elder, is one of the most widely used botanical ingredients in immune health dietary supplements, valued for its high anthocyanin content, antioxidant capacity, and clinical evidence supporting reduction in the duration and severity of cold and influenza symptoms. Its characteristic phytochemical profile includes anthocyanins (primarily cyanidin-3-O-sambubioside, cyanidin-3-O-glucoside, cyanidin-3-O-sambubioside-5-O-glucoside, and cyanidin-3,5-O-diglucoside), flavonols (rutin, quercetin, isorhamnetin glycosides), hydroxycinnamic acids (chlorogenic acid, neochlorogenic acid), and triterpenes (α- and β-amyrin, ursolic acid). HPTLC identity testing generates a characteristic chromatographic fingerprint — anchored by the distinctive cyanidin-based anthocyanin profile — that is compared against an authenticated S. nigra reference standard to confirm species identity and detect potential adulteration, substitution with other Sambucus species or berry materials, or blending with inferior fruit powders.

A representative sample is accurately weighed and extracted using an appropriate acidified solvent system (e.g., acidified methanol or aqueous ethanol with 0.1% hydrochloric acid) to ensure complete extraction and stabilization of the anthocyanin fraction alongside the flavonol and phenolic acid constituents. The extract is applied alongside a certified S. nigra reference standard and, where applicable, potential adulterant extracts (e.g., other Sambucus species such as S. canadensis or S. ebulus, blueberry, black currant, chokeberry), onto an HPTLC silica gel plate using an automated sample applicator. The plate is developed in a validated solvent system optimized to resolve the characteristic anthocyanin and flavonol constituents of S. nigra. After development, the plate is evaluated under white light — where anthocyanins are visible as characteristic pink-purple bands — and under UV light at 254 nm and 366 nm. Derivatization with Natural Products Reagent A (NP/PEG) may be applied for enhanced visualization of flavonol glycosides under UV 366 nm. The resulting fingerprint pattern is compared visually and, where applicable, by densitometric analysis to the authenticated reference standard in accordance with established HPTLC identity testing guidelines.

Elderberry raw materials are subject to adulteration and species substitution, including replacement with other Sambucus species — notably S. canadensis (American elderberry) and S. ebulus (dwarf elder, which contains toxic alkaloids) — as well as other dark berry materials such as blueberry, black currant, and chokeberry, which share similar color profiles but differ significantly in anthocyanin composition and biological activity. The characteristic anthocyanin profile of S. nigra — dominated by cyanidin sambubioside and glucoside derivatives — provides a highly discriminating fingerprint that distinguishes authentic European elderberry from other berry materials and Sambucus species with different anthocyanin profiles. HPTLC fingerprinting provides a holistic, multi-compound identity confirmation that supports detection of substitution or adulteration not apparent from total anthocyanin content assays alone. This method aligns with USP botanical identity testing guidelines and supports cGMP compliance under 21 CFR 111, ensuring that only correctly identified raw materials are used in finished products.

This test confirms the botanical identity of Eleutherococcus senticosus root powder in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic eleutherosides fingerprint of the sample is compared against a certified Eleutherococcus senticosus reference standard to confirm species authenticity and detect substitution with Panax ginseng, other adaptogens, or unrelated root powders. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using methanol or ethanol-water and applied alongside a certified Eleutherococcus senticosus reference standard onto an HPTLC silica gel plate. The plate is developed in a validated solvent system, derivatized with anisaldehyde-sulfuric acid reagent, and the fingerprint is compared visually and by densitometric scanning to the reference standard in terms of Rf values, band positions, and color profile.

Eleutherococcus senticosus is frequently mislabeled or substituted with Panax ginseng or other adaptogenic roots, and its distinct eleutheroside profile is the key differentiator for identity confirmation. HPTLC provides a rapid and defensible species-level identification, supporting supplier qualification and cGMP compliance under 21 CFR 111.

This test quantifies eleutherosides — the primary bioactive glycosides found in Siberian ginseng (Eleutherococcus senticosus) root — in botanical extracts, raw materials, and dietary supplements using High-Performance Liquid Chromatography (HPLC). Eleutherosides, particularly eleutheroside B (syringin) and eleutheroside E, are the marker compounds used to standardize Eleutherococcus extracts and are associated with the herb's adaptogenic properties, including support for stress response, physical endurance, and immune function. Accurate quantification confirms that the extract meets its declared potency and that the correct botanical material is present. Results are reported as a percentage or in milligrams per gram.

A representative sample is accurately weighed and extracted using aqueous methanol or ethanol, with sonication to ensure complete dissolution of the glycoside fraction. The extract is filtered through a 0.2 µm membrane and analyzed by reversed-phase HPLC on a C18 column, with UV or Photodiode Array (PDA) detection at approximately 220–270 nm. Individual eleutherosides are resolved chromatographically and quantified against a multi-point external calibration curve prepared from certified eleutheroside B and eleutheroside E reference standards. System suitability and quality control standards are run concurrently to confirm method accuracy and precision.

Eleutherococcus senticosus is frequently subject to adulteration and species substitution, and eleutheroside content is the primary basis for extract standardization and label claims. HPLC quantification of individual eleutherosides provides the specificity needed to confirm both the identity and potency of the botanical material, distinguishing genuine Eleutherococcus from adulterants and non-standardized root powders. This test supports raw material qualification and finished product release under 21 CFR 111.

This test quantifies ellagic acid — a naturally occurring polyphenolic dilactone formed from the hydrolysis of ellagitannins and found in a wide range of botanicals including pomegranate (Punica granatum), red raspberries (Rubus idaeus), strawberries (Fragaria spp.), walnuts (Juglans regia), and oak-aged materials — in raw materials, fruit extracts, and dietary supplements using High-Performance Liquid Chromatography (HPLC). Ellagic acid is used as a key potency marker for pomegranate and berry extracts standardized to ellagic acid content, and is increasingly recognized for its antioxidant, anti-inflammatory, antiproliferative, and gut microbiome-modulating properties. Accurate quantification is essential for label claim substantiation and for confirming that the declared ellagic acid content is present in standardized botanical extracts. Results are reported as a percentage or in milligrams per gram or per serving.

A representative sample is accurately weighed and extracted using an appropriate solvent system (e.g., aqueous methanol or dimethyl sulfoxide/methanol) to ensure complete dissolution of ellagic acid, which has limited solubility in purely aqueous solvents. Where the sample contains ellagitannins that may contribute to total ellagic acid upon hydrolysis, an optional acid hydrolysis step (e.g., using dilute hydrochloric acid under reflux) may be applied to convert ellagitannins to free ellagic acid prior to HPLC analysis, with results reported as free ellagic acid or total ellagic acid equivalents as appropriate. The extract is filtered and analyzed by reversed-phase HPLC on a C18 column with UV detection at 254 nm, the characteristic absorption maximum of ellagic acid's extended aromatic chromophore. Quantification is performed against a multi-point external calibration curve prepared from a certified ellagic acid reference standard. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

Ellagic acid's extended aromatic chromophore provides strong UV absorption at 254 nm, making HPLC with UV detection a sensitive and specific method for its quantification without the need for derivatization. Chromatographic separation on a C18 column resolves ellagic acid from co-occurring polyphenols — including ellagitannins, anthocyanins, and flavonoids — present in pomegranate and berry extracts, ensuring that potency results reflect ellagic acid content specifically. The option to include an acid hydrolysis step enables reporting of total ellagic acid equivalents (free ellagic acid plus ellagitannin-derived ellagic acid), which is the most commonly used potency specification for pomegranate extracts standardized to ellagic acid. This method supports label claim substantiation, raw material qualification, and cGMP compliance under 21 CFR 111.

This assay quantifies erythritol, a non-caloric sugar alcohol used in keto, diabetic-friendly, and reduced-sugar products. Using HPLC, it determines erythritol content to verify label accuracy, assess total sweetener load, and ensure compliance with “sugar-free” or “no added sugar” claims—especially in light of growing regulatory and health scrutiny.

Samples are extracted in water or dilute acid and filtered before analysis. The extract is analyzed by HPLC with refractive index detection (or UV, depending on matrix). Quantification is performed using high-purity erythritol standards, with internal standard correction and duplicate runs to ensure accuracy.

Results are reported in g/100 g, g/100 mL, or per serving. The values are compared against formulation targets and declared nutrition label values. Testing confirms appropriate use of natural sweeteners and provides transparency in formulations marketed for metabolic health.

This test quantifies eurycomanone — the primary bioactive quassinoid found in Tongkat Ali (Eurycoma longifolia) root — in raw materials and dietary supplements using High-Performance Liquid Chromatography (HPLC). Eurycomanone is widely recognized as the key marker compound responsible for the herb's traditional use in supporting male vitality, energy, and hormonal balance. Accurate quantification ensures that the botanical extract meets its standardized potency and delivers the expected physiological benefits. Results are reported as a percentage or in milligrams per serving to verify label claims and support cGMP compliance.

A representative sample is accurately weighed and extracted using an appropriate solvent, such as aqueous methanol or water, often aided by sonication or reflux to ensure complete dissolution of the quassinoids. The extract is filtered and analyzed via reversed-phase HPLC equipped with a UV or Photodiode Array (PDA) detector, typically monitored at approximately 238 nm. Quantification is performed by comparing the eurycomanone peak area in the sample against a multi-point calibration curve generated from a certified eurycomanone reference standard. Quality control measures, including blank injections and check standards, are run concurrently to ensure method accuracy and precision.

Tongkat Ali is a highly sought-after botanical ingredient that is frequently subject to economically motivated adulteration, including substitution with inferior species or spiking with synthetic compounds. Quantifying eurycomanone via HPLC provides a highly specific and accurate measure of the extract's true potency and authenticity, distinguishing genuine Eurycoma longifolia from adulterated or low-quality materials. This rigorous testing is essential for brand protection, consumer safety, and meeting strict regulatory requirements for dietary supplement identity and strength under 21 CFR 111.

This test quantifies eurypeptides — the bioactive peptide fraction characteristic of Tongkat Ali (Eurycoma longifolia) root extract — using either the o-phthalaldehyde (OPA) fluorometric assay or the bicinchoninic acid (BCA) colorimetric assay, both of which measure total peptide and protein content as a proxy for eurypeptide concentration. Eurypeptides are the primary standardization marker used to define the potency of Tongkat Ali extracts, and their concentration is directly associated with the extract's adaptogenic and testosterone-supporting bioactivity. Results are reported as a percentage of eurypeptide content relative to extract weight to support label claim verification and cGMP compliance.

A representative sample is weighed and dissolved in a dilute aqueous buffer to prepare a homogeneous solution. For the OPA assay, the sample solution is reacted with the o-phthalaldehyde reagent in the presence of a reducing agent, and fluorescence is measured at an excitation/emission of approximately 340/455 nm. For the BCA assay, the sample is reacted with bicinchoninic acid and copper sulfate at elevated temperature, and absorbance is measured at 562 nm. In both cases, quantification is performed against a multi-point calibration curve prepared from a certified peptide or protein reference standard (typically bovine serum albumin or a defined peptide standard). Results are expressed as percentage eurypeptides relative to the initial sample weight.

Eurypeptide content is the defining potency marker for Tongkat Ali extract and is the standard by which premium extracts are graded and marketed (e.g., 22% eurypeptides). Both the OPA and BCA assays are well-established, validated methods for total peptide quantification and are appropriate for this application given the peptidic nature of the target analytes. The choice between OPA (fluorometric, higher sensitivity) and BCA (colorimetric, broader dynamic range) depends on the expected concentration range and matrix characteristics of the sample.

This test confirms the botanical identity of evening primrose (Oenothera biennis) in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic lipid and phenolic fingerprint of the sample is compared against a certified Oenothera biennis reference standard to confirm species authenticity and detect substitution with other seed oils or botanical materials. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using an appropriate organic solvent and applied alongside a certified evening primrose reference standard onto an HPTLC silica gel plate. The plate is developed in a validated solvent system, derivatized with an appropriate detection reagent, and the resulting fingerprint is compared visually and by densitometric scanning to the reference standard in terms of Rf values, band positions, and color profile.

Evening primrose oil is valued for its GLA content and is subject to substitution with less expensive seed oils. HPTLC identity testing confirms botanical species authenticity, supporting supplier qualification and cGMP compliance under 21 CFR 111.

Nutritional profile assay that characterizes the fatty acid composition by converting lipids into fatty acid methyl esters (FAMEs) and analyzing them via gas chromatography. It provides a detailed breakdown of saturates, monounsaturates, polyunsaturates, and trans fats for accurate nutritional labeling and quality control.

Lipids are extracted from the sample and converted into FAMEs via acid or base-catalyzed esterification. The resulting FAMEs are analyzed using gas chromatography with a flame ionization detector. Retention times and peak areas are compared to known standards, with duplicate runs and internal standards ensuring accuracy.

Results are reported as percentage composition of individual fatty acids relative to total fat. These percentages help assess nutritional quality, verify authenticity, and support compliance with labeling claims.

Nutritional profile assay that characterizes the fatty acid composition by converting lipids into fatty acid methyl esters (FAMEs) and analyzing them via gas chromatography. It provides a detailed breakdown of saturates, monounsaturates, polyunsaturates, and trans fats for accurate nutritional labeling and quality control.

Lipids are extracted from the sample and converted into FAMEs via acid or base-catalyzed esterification. The resulting FAMEs are analyzed using gas chromatography with a flame ionization detector. Retention times and peak areas are compared to known standards, with duplicate runs and internal standards ensuring accuracy.

Results are reported as percentage composition of individual fatty acids relative to total fat. These percentages help assess nutritional quality, verify authenticity, and support compliance with labeling claims.

This test confirms the botanical identity of fennel seed (Foeniculum vulgare Mill.) in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic phytochemical fingerprint of the sample — including key volatile aroma compounds and phenylpropanoids such as trans-anethole — is compared against a certified Foeniculum vulgare reference standard to confirm species authenticity and detect substitution with other Apiaceae family members or unrelated botanical materials. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using an appropriate solvent such as ethanol or dichloromethane and applied alongside a certified Foeniculum vulgare reference standard onto an HPTLC silica gel plate. The plate is developed in a validated solvent system and derivatized with a suitable spray reagent — such as anisaldehyde-sulfuric acid — to visualize the characteristic band pattern. The plate is examined under white light and UV at 254 nm and 366 nm, and the resulting fingerprint is compared visually and by densitometric scanning to the reference standard in terms of Rf values, band positions, and color profile.

Fennel seed is a widely used digestive botanical that belongs to the Apiaceae family, which contains numerous morphologically similar species — some of which, such as poison hemlock (Conium maculatum) and fool's parsley (Aethusa cynapium), are toxic. HPTLC identity testing provides a rapid and defensible species confirmation based on the characteristic phytochemical fingerprint of Foeniculum vulgare, supporting supplier qualification, consumer safety, and cGMP compliance under 21 CFR 111.

This test confirms the botanical identity of fennel seed raw materials using High-Performance Thin-Layer Chromatography (HPTLC). Fennel seed is derived from Foeniculum vulgare Mill. (Apiaceae), a widely used medicinal and culinary herb recognized in major pharmacopoeias including the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). Fennel seed is used in dietary supplements for its carminative, antispasmodic, and digestive support properties, with trans-anethole (typically 60–90% of the essential oil), fenchone, estragole, and various flavonoids including rutin and quercetin derivatives serving as the principal marker compounds. Botanical identity verification is particularly important for fennel seed because it belongs to the Apiaceae (Umbelliferae) family, which contains numerous morphologically similar species — including poison hemlock (Conium maculatum), hemlock water dropwort (Oenanthe crocata), and other potentially toxic umbellifers — that could be inadvertently co-harvested or used as adulterants. HPTLC identity testing generates a characteristic chromatographic fingerprint of the fennel seed extract that is compared against an authenticated reference standard to confirm species identity and detect potential substitution or adulteration.

A representative sample of fennel seed raw material is accurately weighed and extracted using an appropriate solvent system (e.g., methanol or ethanol/water) to produce a total extract enriched in the characteristic phenylpropanoid and flavonoid constituents. For volatile marker profiling, an additional extraction using a non-polar solvent (e.g., dichloromethane or hexane) may be employed to capture trans-anethole and fenchone. The extract is applied alongside a certified Foeniculum vulgare reference standard and, where applicable, reference standards for trans-anethole and fenchone, onto a silica gel 60 F₂₅₄ HPTLC plate using an automated sample applicator to ensure precise, reproducible band placement. The plate is developed in a validated solvent system (e.g., toluene/ethyl acetate) optimized for resolution of fennel seed's characteristic phenylpropanoid and flavonoid markers. After development, the plate is dried and visualized under UV light at 254 nm and 366 nm, followed by derivatization with an appropriate spray reagent (e.g., anisaldehyde-sulfuric acid or Natural Products Reagent A) and heating to reveal the full characteristic fingerprint. The resulting chromatographic pattern — including the positions, colors, and relative intensities of all characteristic zones — is compared with the authenticated reference standard. Identity is confirmed when the sample fingerprint is concordant with the reference. The method is performed in accordance with USP General Chapter <203> (HPTLC) and/or AHPA/AHP HPTLC reference standards.

HPTLC is the preferred method for botanical identity testing of fennel seed because it generates a holistic chromatographic fingerprint of the complex mixture of phenylpropanoids (trans-anethole, fenchone, estragole) and flavonoids that together constitute the authentic chemical profile of Foeniculum vulgare. This multi-marker fingerprint approach is more discriminating than single-marker testing and is capable of detecting adulteration with morphologically similar and potentially toxic Apiaceae species that would not be identified by visual or organoleptic inspection alone. The safety-critical importance of distinguishing authentic fennel from toxic umbellifers makes rigorous botanical identity testing especially important for this ingredient. Botanical identity verification is a mandatory requirement under 21 CFR 111.75 for dietary supplement raw material qualification, and HPTLC identity testing is explicitly recognized as an appropriate identity testing methodology in USP General Chapter <203>.

This test confirms the identity of fisetin (3,3',4',7-tetrahydroxyflavone) — a naturally occurring flavonol found in fruits and vegetables including strawberries, apples, persimmons, and onions, and increasingly used in dietary supplements for its potent antioxidant, senolytic, and neuroprotective properties — in raw materials and dietary supplements using Fourier Transform Infrared Spectroscopy (FTIR). FTIR identity testing generates a characteristic mid-infrared absorption spectrum reflecting the unique molecular bond vibrations of fisetin's hydroxyflavone structure, which is compared against an authenticated fisetin reference spectrum to confirm material identity and detect potential substitution with structurally related flavonoids (e.g., quercetin, luteolin, kaempferol) or other phenolic compounds that may be used as adulterants or diluents.

A representative sample is accurately weighed and prepared for FTIR analysis using attenuated total reflectance (ATR-FTIR), in which the sample is placed directly onto the ATR crystal (typically diamond or zinc selenide) and compressed with a pressure applicator to ensure adequate optical contact. The mid-infrared spectrum is collected over the range of 4000–400 cm⁻¹ at a defined spectral resolution (typically 4 cm⁻¹) with an appropriate number of co-added scans for signal averaging. The resulting spectrum is baseline-corrected and compared against an authenticated fisetin reference spectrum using spectral correlation or library matching algorithms. Key diagnostic absorption bands characteristic of fisetin's hydroxyflavone structure — including the carbonyl stretch (~1650 cm⁻¹), aromatic C=C stretches (~1600 and ~1500 cm⁻¹), and O-H stretching and bending vibrations — are evaluated for conformity with the reference. Identity is confirmed when the sample spectrum meets a defined similarity threshold relative to the certified fisetin reference spectrum.

FTIR spectroscopy provides a rapid, non-destructive, and reagent-free method for identity confirmation of pure or highly standardized active pharmaceutical and nutraceutical ingredients, generating a holistic molecular fingerprint that is highly sensitive to differences in molecular structure and functional group composition. For fisetin — which is structurally similar to other dietary flavonols such as quercetin and luteolin — FTIR provides a practical first-line identity screening tool that can distinguish fisetin from closely related flavonoid adulterants based on characteristic differences in their infrared absorption patterns arising from differences in hydroxylation pattern and ring substitution. This method supports raw material qualification, supplier verification, and cGMP compliance under 21 CFR 111.

This test quantifies forskolin — the primary bioactive diterpene found in the roots of Coleus forskohlii (also known as Plectranthus barbatus) — in botanical extracts, raw materials, and dietary supplements using High-Performance Liquid Chromatography (HPLC). Forskolin is well characterized for its ability to activate adenylyl cyclase and elevate intracellular cyclic AMP (cAMP) levels, a mechanism linked to its effects on metabolism, body composition, thyroid function, and smooth muscle relaxation. Accurate quantification is essential for verifying that standardized Coleus forskohlii extracts meet their declared potency and that the active compound is present at the level required for efficacy. Results are reported as a percentage or in milligrams per gram or per serving.

A representative sample is accurately weighed and extracted using an organic solvent such as methanol, ethanol, or acetonitrile, with sonication or reflux to ensure complete extraction of the diterpene from the botanical matrix. The extract is filtered through a 0.2 µm membrane and analyzed by reversed-phase HPLC on a C18 column, with UV or Photodiode Array (PDA) detection at approximately 220–230 nm. Quantification is performed against a multi-point external calibration curve prepared from a certified forskolin reference standard. Peak identity is confirmed by retention time and UV spectral comparison to the reference standard, and system suitability and quality control standards are run concurrently to confirm method accuracy and precision throughout the analytical run.

Forskolin is the defining marker compound of Coleus forskohlii extracts and is the basis on which these extracts are commercially standardized, typically to 10% or 20% forskolin by weight. Accurate HPLC quantification is therefore essential for confirming that a given extract meets its standardization claim and delivers the expected level of bioactive compound. Coleus forskohlii extracts are also subject to adulteration with non-standardized root powder or other plant materials that contain negligible forskolin, making potency verification a critical quality control step for both raw material qualification and finished product release under 21 CFR 111.

This assay measures fructans, including inulin-type oligosaccharides, using High-Performance Liquid Chromatography with Refractive Index detection (HPLC-RI). The method provides accurate quantification of fructan polymers across raw materials and finished products.

Samples are extracted and analyzed under validated HPLC-RI chromatographic conditions. Fructan fractions are separated based on molecular size and quantified against certified reference standards. Calibration curves and replicate injections ensure accuracy and reproducibility.

Testing verifies fiber content claims, supports prebiotic labeling, and ensures batch-to-batch consistency.

This test quantifies fructans — a class of fructose-based polysaccharides and oligosaccharides including inulin, fructooligosaccharides (FOS), and related fructan chain-length fractions — in raw materials, prebiotic ingredients, and dietary supplements using High-Performance Liquid Chromatography with Refractive Index Detection (HPLC-RI). Inulin and FOS are naturally occurring fructans found in a wide range of plant sources including chicory root (Cichorium intybus), Jerusalem artichoke (Helianthus tuberosus), agave (Agave spp.), and garlic (Allium sativum), and are among the most extensively studied prebiotic dietary fibers. HPLC-RI provides the ability to resolve and quantify individual fructan chain-length fractions — including the short-chain FOS oligomers (GF2, GF3, GF4) and longer-chain inulin polymers — as well as the total fructan content, supporting label claim verification and characterization of the degree of polymerization (DP) distribution. Results are reported as a percentage or in milligrams per gram or per serving of total fructans, with individual chain-length fractions reported where applicable.

A representative sample is accurately weighed and dissolved in an appropriate aqueous diluent (hot water or dilute buffer) to ensure complete dissolution of the fructan fraction. The solution is filtered and analyzed by HPLC using a dedicated carbohydrate analysis column — typically an amino-bonded silica column or a calcium-form ion-exchange column — with Refractive Index (RI) detection, which provides a universal, non-selective response to all carbohydrate species without the need for derivatization. Chromatographic conditions are optimized to resolve individual FOS oligomers (GF2 = 1-kestose, GF3 = nystose, GF4 = fructosylnystose) from free fructose, glucose, and sucrose, and to characterize the longer-chain inulin polymer fraction. Quantification is performed against a multi-point external calibration curve prepared from certified inulin and FOS reference standards. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

Refractive Index detection is the preferred detection mode for fructan and inulin analysis by HPLC because fructans lack a UV chromophore and are therefore not amenable to UV detection without derivatization. RI detection provides a universal, matrix-independent response to all carbohydrate species, enabling simultaneous quantification of the full fructan chain-length distribution — from short-chain FOS oligomers to long-chain inulin polymers — in a single analytical run. This approach supports characterization of the degree of polymerization profile, which is an important quality attribute for inulin and FOS ingredients as it influences prebiotic activity, solubility, and viscosity. The method supports label claim substantiation, raw material qualification, and cGMP compliance under 21 CFR 111.

This assay quantifies fructose, a simple monosaccharide sugar commonly present in fruits, sweeteners, and functional beverages. Using LC-MS/MS, it measures fructose content in raw ingredients and finished products to verify label claims, confirm sugar composition, and detect adulteration or undeclared sugars.

Samples are extracted in water or dilute solvent and analyzed by LC-MS/MS with compound-specific mass transitions. Quantification is performed using certified fructose standards, with internal standard correction and duplicate injections to ensure accuracy and reproducibility.

Results are reported in g per 100 g, g per 100 mL, or per serving. Values are compared to nutrition label claims and formulation targets to confirm accuracy, ensure compliance, and support “no added sugar” or “low sugar” claims.

This assay quantifies gamma-aminobutyric acid (GABA), a naturally occurring inhibitory neurotransmitter used in calming, sleep, and mood-support supplements. Using LC-MS/MS, it verifies GABA content in capsules, powders, and functional beverages to confirm label claims and ensure consistent therapeutic dosing.

Samples are extracted using aqueous or acidified solvents and analyzed by LC-MS/MS with compound-specific mass transitions. Quantification is performed using certified GABA standards with internal standard correction and duplicate injections to ensure precision and reproducibility.

Results are reported in mg per g or per serving. Values are compared to formulation targets and declared label claims to confirm active content and detect degradation or underformulation.

This assay measures gamma-butyrobetaine (GBB), a key intermediate in the biosynthesis of L-carnitine, using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). The method provides high sensitivity and selectivity for accurate quantification in raw materials and finished products.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. GBB is detected using multiple reaction monitoring (MRM) and quantified against certified reference standards. Internal calibration and quality control checks ensure accuracy and reproducibility across matrices.

Testing verifies label claims, confirms ingredient purity, and ensures consistent dosing in GBB-containing formulations.

This test quantifies gamma-linolenic acid (GLA), an important omega-6 fatty acid commonly present in oils from evening primrose, borage, and black currant seeds. Measuring GLA content ensures product quality and consistency across raw materials, oils, and finished supplements. The analysis is performed using High-Performance Liquid Chromatography (HPLC) with a detection limit suitable for reporting GLA concentration in mg/g or percentage of total fatty acids.

Samples are first saponified and then methylated to convert fatty acids into their methyl esters using methanolic potassium hydroxide and boron trifluoride-methanol reagents. The resulting fatty acid methyl esters (FAMEs) are extracted into hexane and injected into an HPLC system equipped with a reversed-phase C18 column. Detection is performed using an evaporative light scattering detector (ELSD) to specifically measure GLA methyl esters. Quantification is achieved by comparing peak areas to a calibration curve constructed from certified GLA methyl ester standards. Method accuracy is confirmed through duplicate injections, inclusion of quality control samples, and spike recovery tests to validate extraction and detection efficiency.

Results are reported in % w/w (raw material) or mg/serving (finished products). Testing verifies oil standardization, supports label claims, and ensures consistency across batches in fatty acid–based formulations.

This test quantifies geranylgeraniol (GGOH) — a naturally occurring diterpene alcohol found in annatto (Bixa orellana) seeds and certain other botanical sources, and used in dietary supplements to support mitochondrial function, coenzyme Q10 biosynthesis, and the replenishment of isoprenoid intermediates depleted by statin medications — in raw materials and finished products using Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS). Accurate potency verification is essential for confirming that the declared amount of this premium, low-dose active is present in the finished product. Results are reported in milligrams per gram or per serving.

A representative sample is accurately weighed and extracted using an organic solvent such as methanol, ethanol, or acetonitrile, with sonication to ensure complete dissolution of the lipophilic diterpene alcohol. An isotopically labeled or structurally analogous internal standard is added prior to extraction to correct for matrix effects and recovery variability. The extract is filtered and analyzed by reversed-phase LC-MS/MS on a C18 column, with detection by electrospray ionization (ESI) or atmospheric pressure chemical ionization (APCI) using multiple reaction monitoring (MRM) transitions specific to geranylgeraniol. Quantification is performed against a multi-point external calibration curve prepared from a certified GGOH reference standard. Quality control samples are run concurrently to confirm method accuracy and precision throughout the analytical run.

Geranylgeraniol is a high-value, low-dose active ingredient typically dosed in the range of 150–300 mg per serving, making accurate potency verification critical for label claim substantiation. LC-MS/MS with MRM detection provides the sensitivity and compound-specific selectivity needed to quantify GGOH at relevant concentrations in complex supplement matrices, distinguishing it from structurally related isoprenoid compounds such as geraniol, farnesol, and geranylgeranyl pyrophosphate. This level of analytical rigor supports raw material qualification, label claim compliance, and cGMP requirements under 21 CFR 111.

This panel quantifies major bioactive compounds in ginger, including gingerols and shogaols. Using HPLC, it measures six key analytes—6-gingerol, 8-gingerol, 10-gingerol, 6-shogaol, 8-shogaol, and 10-shogaol—to verify potency, support standardization, and ensure label accuracy in functional foods, extracts, and digestive supplements.

Samples are extracted using alcohol-based solvents under light- and heat-controlled conditions. The extract is analyzed by HPLC with UV detection at compound-specific wavelengths. Quantification is performed using certified standards for each gingerol and shogaol, with internal standard correction and duplicate injections to ensure accuracy.

Results are reported in mg per g or per serving for each compound. Values are compared to formulation targets and label claims to confirm active content, assess extract quality, and detect degradation due to heat or improper storage.

This panel quantifies the primary gingerol compounds found in ginger root: 6-gingerol, 8-gingerol, and 10-gingerol. Using HPLC, it measures each compound individually and calculates total gingerols to support standardization in functional foods, herbal extracts, and digestive health supplements.

Samples are extracted with alcohol-based solvents under temperature- and light-controlled conditions. The extract is analyzed by HPLC with UV detection at a compound-specific wavelength. Quantification is performed using certified gingerol standards, with internal standard correction and duplicate injections for precision.

Results are reported in mg per g or per serving for each compound and total gingerols. Values are compared to formulation targets and label claims to verify potency, support consistency, and detect degradation or variability in botanical source material.

This test simultaneously identifies and quantifies the three principal gingerol homologs — 6-gingerol, 8-gingerol, and 10-gingerol — and reports their sum as total gingerols in ginger (Zingiber officinale Roscoe) raw materials, dried powders, extracts, and dietary supplements using High-Performance Liquid Chromatography (HPLC). Gingerols are the primary pungent phenylalkylketone constituents of fresh and minimally processed ginger rhizome, and total gingerol content is the most widely used potency specification for standardized ginger extracts in the dietary supplement industry. Among the three homologs, 6-gingerol is typically the most abundant, but 8-gingerol and 10-gingerol contribute meaningfully to the total gingerol content and overall bioactive profile. Individual quantification of each homolog alongside the total gingerol sum provides a more complete and accurate potency characterization than single-marker 6-gingerol assays alone. Results are reported in milligrams per gram or as a percentage for each individual gingerol and as a combined total gingerol value.

A representative sample is accurately weighed and extracted using an appropriate organic solvent system (e.g., methanol or aqueous methanol) to ensure complete extraction of the gingerol fraction. The extract is filtered and analyzed by reversed-phase HPLC on a C18 column with UV detection at 282 nm, the characteristic absorption maximum of the phenylalkylketone chromophore shared by all gingerol homologs. Chromatographic conditions (mobile phase gradient, column temperature, and flow rate) are optimized to achieve baseline resolution of 6-gingerol, 8-gingerol, and 10-gingerol, which elute in order of increasing carbon chain length and decreasing polarity. Quantification of each individual gingerol homolog is performed against a multi-point external calibration curve prepared from certified reference standards for each compound. Total gingerols are reported as the sum of the three individually quantified gingerol concentrations. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

Quantification of all three gingerol homologs — rather than 6-gingerol alone — provides a more accurate and complete measure of total gingerol potency, as 8-gingerol and 10-gingerol are present in meaningful concentrations in most ginger materials and contribute to the total pungent bioactive content. Reporting individual homolog concentrations alongside the total gingerol sum also provides quality-relevant compositional information, as the relative homolog distribution can vary with ginger variety, geographic origin, and processing conditions. This comprehensive approach supports label claim substantiation for total gingerol specifications, raw material qualification, and cGMP compliance under 21 CFR 111.

This test simultaneously identifies and quantifies six key bioactive phenylalkylketone compounds in ginger (Zingiber officinale Roscoe) — specifically 6-gingerol, 8-gingerol, 10-gingerol, 6-shogaol, 8-shogaol, and 10-shogaol — in raw materials, dried ginger powders, extracts, and dietary supplements using High-Performance Liquid Chromatography (HPLC). Gingerols are the principal pungent constituents of fresh ginger rhizome, while shogaols — formed by dehydration of gingerols during drying and processing — predominate in dried ginger and heat-processed extracts. The relative ratio of gingerols to shogaols provides important information about the processing history and quality of the ginger material. The 6-homologs are typically the most abundant within each series, but the 8- and 10-homologs contribute meaningfully to the overall bioactive profile and pungency. Comprehensive panel quantification supports label claim verification, raw material authentication, and detection of adulteration or over-processing. Results are reported in milligrams per gram or as a percentage for each individual compound and as combined gingerol and shogaol totals.

A representative sample is accurately weighed and extracted using an appropriate organic solvent system (e.g., methanol or aqueous methanol) to ensure complete extraction of the gingerol and shogaol series. The extract is filtered and analyzed by reversed-phase HPLC on a C18 column with UV detection at 282 nm, the characteristic absorption maximum of the phenylalkylketone chromophore shared by all gingerol and shogaol homologs. Chromatographic conditions (mobile phase gradient, column temperature, and flow rate) are optimized to achieve baseline resolution of all six target compounds, which elute in order of increasing carbon chain length and decreasing polarity. Quantification of each individual compound is performed against a multi-point external calibration curve prepared from certified reference standards for each gingerol and shogaol homolog. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

A comprehensive gingerol and shogaol panel by HPLC provides significantly more informative potency and quality data than single-marker 6-gingerol assays alone. The relative proportions of gingerols to shogaols serve as a reliable indicator of raw material processing history — fresh or minimally processed ginger is characterized by a high gingerol-to-shogaol ratio, while dried, heat-processed, or aged materials show elevated shogaol levels due to thermal dehydration of gingerols. Simultaneous quantification of all six homologs enables detection of adulteration, over-processing, or blending of fresh and dried ginger materials, and provides a complete characterization of the pungent bioactive fraction. This approach supports label claim substantiation, raw material qualification, and cGMP compliance under 21 CFR 111.

This test confirms the botanical identity of ginger (Zingiber officinale) in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). HPTLC produces a characteristic chromatographic fingerprint based on ginger's bioactive gingerol and shogaol compounds, which is compared against a certified Zingiber officinale reference standard to confirm species authenticity and detect substitution or adulteration. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using methanol or ethanol and applied alongside a certified ginger reference standard onto an HPTLC silica gel plate using an automated applicator. The plate is developed in a validated solvent system, dried, and derivatized with a detection reagent such as anisaldehyde-sulfuric acid or vanillin-sulfuric acid to visualize the characteristic gingerol and shogaol marker bands. The resulting fingerprint is compared visually and by densitometric scanning to the reference standard pattern. Identity is confirmed when the sample fingerprint matches the reference in terms of Rf values, band positions, and color profile, per established HPTLC botanical identity methods.

Ginger is a high-volume botanical ingredient subject to adulteration with related Zingiberaceae species or dilution with non-botanical fillers. HPTLC identity testing provides a rapid, cost-effective, and scientifically defensible confirmation of botanical species, supporting supplier qualification, label accuracy, and compliance with cGMP identity testing requirements under 21 CFR 111.

This panel quantitatively analyzes eight major ginsenosides—Rb1, Rb2, Rc, Rd, Re, Rf, Rg1, and Rg2—in Panax ginseng extracts, powders, and supplements. Using LC‑MS/MS, it provides detailed profiling for quality control, authenticity verification, and label compliance in adaptogenic and longevity-focused formulations.

Samples are extracted using methanol–water solvent under controlled conditions. The extract is analyzed by LC‑MS/MS with multiple reaction monitoring (MRM) transitions optimized for each ginsenoside. Quantification uses certified reference standards and internal standard correction, with duplicate injections ensuring precision. Calibration spans ~0.5–200 ng/mL for each analyte

Results are reported in mg per g or per serving for each compound and total ginsenosides. Values are compared to botanical standardization targets and label claims to confirm extract potency, detect adulteration, and ensure consistency across batches.

This assay quantifies glucomannan (konjac-derived soluble fiber) using a UV-Vis colorimetric method. The procedure isolates the glucomannan fraction and determines polysaccharide content by absorbance against a calibrated standard curve.

Samples are extracted in aqueous/alcohol conditions with cleanup (e.g., enzyme/starch removal and ethanol precipitation) to enrich the glucomannan fraction. The purified fraction is reacted with colorimetric reagents (e.g., phenol–sulfuric acid), and absorbance is measured by UV-Vis; results are calculated from a konjac glucomannan or D-glucose standard curve with duplicate runs and QC checks.

Results are reported as % w/w or mg/g glucomannan. Values are compared to specification targets and label claims to verify fiber standardization and detect dilution or substitution.

This test confirms the identity of konjac glucomannan — a high-molecular-weight, water-soluble polysaccharide derived from the corm of the konjac plant (Amorphophallus konjac K. Koch) — in raw materials, flour powders, and dietary supplements using High-Performance Thin-Layer Chromatography (HPTLC). Amorphophallus konjac is a perennial plant native to East and Southeast Asia, and its corm-derived glucomannan is one of the most viscous dietary fibers known, widely used in dietary supplements for weight management, satiety, glycemic control, and cholesterol support. HPTLC identity testing of glucomannan-containing materials typically employs acid hydrolysis to release the characteristic monosaccharide constituents — primarily glucose and mannose in an approximately 2:5 molar ratio — which are then resolved and visualized as a diagnostic sugar fingerprint compared against an authenticated A. konjac reference standard to confirm identity and detect potential adulteration or substitution with other polysaccharide-containing materials.

A representative sample is accurately weighed and subjected to complete acid hydrolysis (e.g., using dilute sulfuric or hydrochloric acid under reflux conditions) to hydrolyze the glucomannan polysaccharide into its constituent monosaccharides. The hydrolysate is neutralized, filtered, and applied alongside an authenticated A. konjac glucomannan hydrolysate reference standard and, where applicable, reference monosaccharide standards (glucose, mannose) and potential adulterant hydrolysates, onto an HPTLC silica gel plate using an automated sample applicator. The plate is developed in a validated aqueous-organic solvent system optimized for monosaccharide resolution. After development, the plate is derivatized with an appropriate sugar-visualizing reagent (e.g., diphenylamine-aniline-phosphoric acid or anisaldehyde-sulfuric acid) and evaluated under white light and UV light. The resulting monosaccharide fingerprint — characterized by the characteristic glucose and mannose band pattern in the approximately 2:5 ratio diagnostic of konjac glucomannan — is compared visually and, where applicable, by densitometric analysis to the authenticated reference standard in accordance with established HPTLC identity testing guidelines.

Konjac glucomannan is subject to adulteration and substitution with lower-cost polysaccharide materials — including other glucomannans, starches, cellulose derivatives, and guar gum — that may be visually indistinguishable in dried powder form. HPTLC monosaccharide fingerprinting following acid hydrolysis provides a practical and discriminating identity confirmation method that exploits the characteristic glucose-to-mannose ratio of konjac glucomannan to distinguish it from other polysaccharide adulterants with different monosaccharide compositions. This method aligns with USP botanical identity testing guidelines and supports cGMP compliance under 21 CFR 111, ensuring that only correctly identified raw materials are used in finished products.

This test quantifies glucoraphanin, the primary glucosinolate precursor to sulforaphane found in broccoli (Brassica oleracea) and broccoli seed extracts, in dietary supplements and raw materials using Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS). Glucoraphanin is the defining potency and standardization marker for broccoli sprout and broccoli seed extracts, and its concentration determines the theoretical yield of sulforaphane upon enzymatic conversion by myrosinase. LC-MS/MS is the preferred method for glucoraphanin quantification due to its high sensitivity and ability to distinguish glucoraphanin from co-present glucosinolates in complex botanical matrices. Results are reported in mg per serving or µmol per gram to support label claim verification and cGMP compliance.

A representative sample is weighed and extracted using a methanol-water solvent system with sonication, with care taken to inactivate endogenous myrosinase activity — typically by using boiling water or methanol — to prevent enzymatic hydrolysis of glucoraphanin during sample preparation. The clarified extract is injected onto a reversed-phase C18 HPLC column coupled to a triple quadrupole mass spectrometer operating in negative ionization Multiple Reaction Monitoring (MRM) mode, as glucosinolates ionize efficiently under negative ESI conditions. Specific precursor-to-product ion transitions characteristic of glucoraphanin are monitored for quantification and identity confirmation. Quantification is performed against a multi-point calibration curve prepared from a certified glucoraphanin reference standard, with a stable isotope-labeled internal standard used to correct for matrix effects and ensure accurate recovery.

Glucoraphanin is the primary bioactive precursor in broccoli-derived supplements and its accurate quantification is essential for verifying extract potency and substantiating label claims, particularly for products marketed on the basis of sulforaphane yield. LC-MS/MS in negative ionization MRM mode provides the molecular specificity required to distinguish glucoraphanin from the 100+ other glucosinolates present in Brassica matrices — including glucoerucin, glucobrassicin, and sinigrin — which cannot be reliably resolved by HPLC-UV alone, ensuring accurate and defensible potency data for this high-value ingredient category.

This assay quantifies glucosamine, a key structural compound used in joint support supplements, typically in the form of glucosamine sulfate or glucosamine HCl. Using LC-MS/MS, it confirms active content in capsules, tablets, and powders to support label accuracy and formulation consistency.

Samples are extracted in aqueous solution and analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed using certified glucosamine standards, with internal standard correction and duplicate injections to ensure precision.

Results are reported in mg per g or per serving. Values are compared to label claims and formulation targets to confirm proper dosing and detect possible degradation or underformulation.

This assay quantifies glucose, a monosaccharide sugar commonly found in foods, beverages, and supplements. Using LC-MS/MS, it measures glucose content in raw materials and finished products to verify label claims, confirm sugar composition, and detect undeclared or added sugars.

Samples are extracted in water or dilute solvents and analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed with certified glucose standards, applying internal standard correction and duplicate injections to ensure precision and reproducibility.

Results are reported in g per 100 g, g per 100 mL, or per serving. Values are compared against nutrition label claims and formulation targets to confirm accuracy, ensure regulatory compliance, and support “low sugar” or “no added sugar” claims.

This test quantifies glucuronolactone — a naturally occurring compound derived from glucose metabolism and commonly used as a functional ingredient in energy drinks and dietary supplements — in finished products and raw materials using Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS). Glucuronolactone is included in formulations for its purported role in supporting detoxification, liver function, and energy metabolism, and accurate quantification is important for label claim verification and compliance with declared ingredient levels. LC-MS/MS provides the sensitivity and specificity needed to accurately measure glucuronolactone in complex beverage and supplement matrices. Results are reported in milligrams per gram or per serving.

A representative sample is accurately weighed or measured and dissolved in an aqueous solvent, with protein precipitation or dilution as needed to prepare a clean matrix for injection. An isotopically labeled or structurally analogous internal standard is added prior to sample preparation to correct for matrix effects and recovery variability. The sample is filtered and analyzed by reversed-phase or HILIC LC-MS/MS, with detection performed in positive or negative electrospray ionization (ESI) mode using multiple reaction monitoring (MRM) transitions specific to glucuronolactone. Quantification is performed against a multi-point external calibration curve prepared from a certified glucuronolactone reference standard. Quality control samples are run concurrently to confirm method accuracy and precision.

Glucuronolactone is a declared functional ingredient in a wide range of energy and wellness products, and accurate quantification is necessary to substantiate label claims and ensure that the product delivers the stated dose. LC-MS/MS is the preferred method due to its high sensitivity and compound-specific MRM detection, which provides reliable quantification in complex matrices such as energy drinks and multi-ingredient supplement blends where co-eluting compounds may interfere with less selective methods.

This assay quantifies reduced glutathione (GSH), the bioactive form of glutathione, in oral supplements including standard capsules, powders, and liposomal products. Using HPLC, it verifies glutathione potency and ensures that the compound is present in its reduced, effective form—critical for products marketed for detoxification, oxidative stress, and skin health.

Samples are extracted under light- and oxygen-protected conditions to prevent oxidation. The extract is analyzed by HPLC with detection at a compound-specific wavelength. Quantification is performed using high-purity reduced glutathione standards, with internal standard correction and duplicate injections to ensure accuracy.

Results are reported in mg per g or per serving. Values are compared with formulation targets and label claims. Testing confirms glutathione stability and bioactive content, and helps validate antioxidant and detox claims while detecting potential degradation or oxidation over time.

This test quantifies total glycosaponins in botanical extracts — most commonly Tribulus terrestris — and raw materials using UV-Visible (UV-Vis) spectrophotometry. Glycosaponins are a class of steroidal or triterpenoidal saponin glycosides that serve as the primary potency and standardization marker for Tribulus and related adaptogenic ingredients. The UV-Vis method measures total saponin content via a colorimetric reaction, providing a rapid and cost-effective assessment of extract potency. Results are reported as a percentage of glycosaponin content relative to extract weight to support label claim verification and cGMP compliance.

A representative sample is weighed and extracted using a methanol or ethanol-water solvent system with sonication or reflux. The extract is reacted with a chromogenic reagent — typically vanillin-sulfuric acid or perchloric acid — which produces a colored complex with the saponin fraction. Absorbance is measured by UV-Vis spectrophotometry at approximately 540–560 nm depending on the reagent system used. Quantification is performed against a multi-point external calibration curve prepared from a certified saponin reference standard (such as diosgenin or oleanolic acid). Results are expressed as percentage glycosaponins relative to the initial sample weight.

Glycosaponin content is the industry-standard potency marker for Tribulus terrestris extract and is the primary specification used to differentiate extract grades. UV-Vis spectrophotometry with colorimetric derivatization is the conventional and widely accepted method for total saponin quantification in botanical extracts, providing a practical and reproducible measure of extract potency for both raw material qualification and finished product release testing.

This assay measures glycyrrhizic acid (also known as glycyrrhizin), a triterpenoid saponin glycoside, using High-Performance Liquid Chromatography (HPLC). The analysis provides accurate quantification for quality control and standardization purposes.

Samples are extracted and analyzed under validated HPLC chromatographic conditions. Glycyrrhizic acid is separated from related compounds and detected via UV or diode-array detection. Quantitation is performed using certified reference standards, with calibration curves and replicate injections ensuring accuracy and reproducibility.

Testing verifies standardized potency, confirms label claims, and ensures batch-to-batch consistency.

This test confirms the botanical identity of goji berry raw materials — including whole dried fruit, fruit powder, juice powder, concentrates, and extracts — using High-Performance Thin-Layer Chromatography (HPTLC). Goji berry, also known as wolfberry, is derived from the fruit of Lycium barbarum L. (Solanaceae). It is widely used in dietary supplements and functional foods as a source of naturally occurring polysaccharides, carotenoids, phenolic compounds, and other characteristic phytochemicals. HPTLC identity testing produces a multi-component chromatographic fingerprint from the sample and compares it with authenticated L. barbarum reference material. The profile may include characteristic zones associated with the material’s phenolic, flavonoid, and other extractable constituents, with the overall pattern — rather than a single compound alone — used to support identity determination. This approach is important because commercially traded goji materials may be confused with, substituted by, or blended with related Lycium species, particularly Lycium chinense, as well as with other dried berry materials. The assay is qualitative and is intended to confirm botanical identity; it does not quantify polysaccharides, carotenoids, zeaxanthin dipalmitate, or other individual nutritional or active constituents.

A representative sample is accurately weighed and extracted with a validated solvent system, such as aqueous methanol or aqueous ethanol, selected to recover the characteristic polar and moderately polar constituents of goji fruit. Sample preparation may be adjusted for high-sugar, high-pigment, or highly processed matrices to minimize chromatographic interference. The clarified extract is applied alongside authenticated Lycium barbarum reference material and, where included within the validated method scope, qualified phytochemical reference standards onto a silica gel 60 F₂₅₄ HPTLC plate using an automated sample applicator. The plate is developed in a validated mobile-phase system optimized to resolve characteristic goji berry zones. After development, the plate is dried and evaluated under UV light at 254 nm and 366 nm. A suitable derivatization reagent, such as Natural Products Reagent/polyethylene glycol or anisaldehyde-sulfuric acid, may be applied to enhance visualization of characteristic constituents. The retention-factor values, zone colors, fluorescence responses, and relative intensities of the sample fingerprint are compared with the authenticated reference profile. Identity is confirmed when the sample demonstrates concordance with the validated L. barbarum fingerprint. System-suitability standards, blanks, and concurrent quality-control samples are assessed with each analytical run.

Morphological identification of goji berry becomes unreliable once fruit has been powdered, extracted, concentrated, or incorporated into a finished formulation. HPTLC provides a rapid and information-rich identity tool by evaluating the collective chemical fingerprint of the material, rather than relying on visual examination or a single marker that may vary with cultivar, origin, ripeness, processing, and storage. Comparison with authenticated L. barbarum reference material enables differentiation of the declared botanical source from related Lycium materials or potential berry-based substitutes. This method supports botanical raw-material qualification, supplier verification, and dietary supplement cGMP identity-testing requirements under 21 CFR 111.75, using a fit-for-purpose chromatographic approach consistent with USP General Chapter <203>.

This test confirms the botanical identity of Gotu Kola (Centella asiatica) in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic triterpenoid fingerprint — including asiaticoside, madecassoside, asiatic acid, and madecassic acid — of the sample is compared against a certified Centella asiatica reference standard to confirm species authenticity and detect substitution with other Apiaceae family members or unrelated botanical materials. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using methanol or ethanol-water and applied alongside a certified Centella asiatica reference standard onto an HPTLC silica gel plate. The plate is developed in a validated solvent system, derivatized with anisaldehyde-sulfuric acid reagent, and the fingerprint is compared visually and by densitometric scanning to the reference standard in terms of Rf values, band positions, and color profile.

Centella asiatica is subject to substitution with other Apiaceae species that share a similar appearance but lack the characteristic centelloside triterpenoid profile responsible for its bioactivity. HPTLC identity testing provides a rapid and defensible species confirmation based on this unique triterpenoid fingerprint, supporting supplier qualification and cGMP compliance under 21 CFR 111.

This assay measures characteristic grape seed marker compounds using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). Analysis typically targets proanthocyanidins (OPCs) and related polyphenols to confirm ingredient identity and standardized active content.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. Target grape seed markers are detected using multiple reaction monitoring (MRM) and quantified against certified reference standards. Internal calibration and quality control checks ensure accuracy and reproducibility.

Testing verifies authenticity, supports label claims (e.g., OPC content), and ensures batch-to-batch consistency in grape seed–based formulations.

This test confirms the species identity of green-lipped mussel (Perna canaliculus) in raw materials and finished products using DNA sequencing. By targeting species-specific genetic markers, this method provides definitive molecular confirmation that the material is derived from Perna canaliculus — the New Zealand green-lipped mussel — and not from lower-cost mussel species or other marine shellfish. DNA sequencing is the gold standard for species authentication, providing an unambiguous identity result that cannot be replicated by morphological or chemical marker methods alone. Results are reported as confirmed species identity or non-conforming.

DNA is extracted from a representative sample using a validated extraction protocol appropriate for processed marine ingredients, which may include proteinase K digestion and silica-based column purification to recover sufficient DNA from heat-treated or hydrolyzed matrices. A target region of mitochondrial DNA — typically the cytochrome c oxidase subunit I (COI) gene, the standard barcode locus for animal species identification — is amplified by PCR using primers designed to amplify the target region across mussel species. The amplified product is sequenced by Sanger sequencing or next-generation sequencing (NGS), and the resulting sequence is compared against a curated reference database (e.g., BOLD, GenBank) to confirm species identity. Results are reported as a percentage match to the Perna canaliculus reference sequence.

Green-lipped mussel is a premium marine ingredient sourced exclusively from New Zealand, commanding a significant price premium over common blue mussel (Mytilus spp.) and other shellfish species. DNA sequencing provides the definitive species-level authentication needed to confirm that a product contains genuine Perna canaliculus and has not been substituted with or adulterated by other mussel species that lack the unique lipid and glycosaminoglycan profile associated with green-lipped mussel's joint health benefits. This test supports supplier qualification, label claim accuracy, and consumer transparency for a high-value, geographically specific marine ingredient.

This assay measures characteristic green tea marker compounds using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). Analysis typically targets catechins and related polyphenols to confirm ingredient identity and standardized active content.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. Target green tea markers are detected using multiple reaction monitoring (MRM) and quantified against certified reference standards. Internal calibration and quality controls ensure accuracy and reproducibility.

Testing verifies authenticity, supports label claims, and ensures batch-to-batch consistency in green tea–based formulations.

This assay quantifies insulin-like growth factor 1 (IGF-1), a key bioactive in colostrum and performance supplements. Using LC-MS/MS, it delivers high-specificity detection for ingredient verification.

Samples are extracted, purified, and analyzed by LC-MS/MS with compound-specific mass transitions. Internal standards and calibration curves are used for quantification.

Results are reported in ng/g or ng per serving. Validates the presence of growth factors for recovery and immune-support formulations.

This test measures the concentration of transforming growth factor beta 2 (TGF-β2), a key regulatory protein involved in gut health and immune system modulation. The assay employs LC-MS/MS to provide sensitive and specific quantification in various matrices including raw materials, finished products, and supplements. Results are reported in ng/mL or ng/g, with detection limits suitable for low-level protein analysis.

Samples undergo enzymatic digestion to release TGF-β2 peptides, followed by solid-phase extraction for purification. The purified extracts are analyzed using LC-MS/MS in multiple reaction monitoring (MRM) mode, targeting specific peptide transitions. Quantification is achieved using calibration curves prepared from reference standards and normalized with isotopically labeled internal standards. Method validation includes duplicate injections, quality control samples, and spike recovery assessments to ensure accuracy and precision.

Results are reported in ng/g. Confirms growth factor enrichment in colostrum and specialized nutritional blends.

This assay measures guanidinoacetic acid (GAA), a natural precursor to creatine biosynthesis, using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). The method provides high sensitivity and selectivity for accurate quantification in raw materials and finished formulations.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. GAA is detected in multiple reaction monitoring (MRM) mode and quantified using certified reference standards. Internal calibration and quality control checks ensure precision, accuracy, and reproducibility.

Testing verifies label claims, confirms raw material purity, and ensures consistent dosing in creatine-enhancing supplements.

This test confirms the identity of guar gum, the high-molecular-weight galactomannan obtained principally from the endosperm of the seed of Cyamopsis tetragonoloba (L.) Taub. (Fabaceae), using High-Performance Thin-Layer Chromatography (HPTLC). Guar gum is widely used in dietary supplements, foods, and functional formulations as a viscosity modifier, stabilizer, binder, soluble-fiber source, and controlled-release excipient. Its principal structural feature is a β-(1→4)-linked mannan backbone with α-(1→6)-linked galactose side groups. Following controlled hydrolysis, HPTLC produces a characteristic monosaccharide profile dominated by mannose and galactose. Comparison with an authenticated guar-gum reference material and qualified monosaccharide standards supports confirmation of the material’s galactomannan identity and assists in assessing potential substitution, dilution, or admixture with other hydrocolloids, such as locust bean gum, tara gum, xanthan gum, cellulose derivatives, starches, or dextrins. This is a qualitative identity test and does not establish viscosity, molecular weight, galactomannan content, microbiological quality, or compliance with a specific finished-product fiber claim.

A representative sample is accurately weighed and dispersed in purified water under controlled heating and mixing conditions to obtain a homogeneous gum solution. An aliquot is subjected to validated acid or enzymatic hydrolysis to depolymerize the galactomannan into its constituent monosaccharides without excessive degradation. The hydrolysate is neutralized as needed, clarified by centrifugation and filtration, and applied alongside authenticated guar-gum reference material and qualified D-mannose and D-galactose reference standards onto a silica gel HPTLC plate using an automated sample applicator. The plate is developed in a validated solvent system suitable for carbohydrate separation, commonly an acetonitrile/water-based system or another validated sugar-separation mobile phase. Following development and drying, the plate is derivatized with a carbohydrate-selective visualization reagent, such as an aniline–diphenylamine–phosphoric acid reagent or another validated reducing-sugar reagent, then heated under controlled conditions to develop characteristic zones. The retention factors, colors, and relative responses of the mannose and galactose zones — together with the overall hydrolysate profile — are compared against the guar-gum reference material. Identity is confirmed when the sample profile is concordant with the validated reference fingerprint. Blanks, system-suitability standards, duplicate preparations, and quality-control samples are included with each analytical batch.

Guar gum is a polymeric carbohydrate for which visual inspection and many simple physical tests cannot reliably confirm botanical source or distinguish it from other commercially traded galactomannans. HPTLC following controlled hydrolysis provides a direct, practical means to evaluate the monosaccharide fingerprint characteristic of guar gum. The relative mannose and galactose pattern offers meaningful discrimination from other plant-derived gums with different galactose-substitution patterns, while comparison to an authenticated reference material provides broader identity assurance than testing for a single sugar alone. This method supports incoming raw-material qualification, supplier verification, and dietary supplement cGMP identity-testing requirements under 21 CFR 111.75 using a fit-for-purpose chromatographic approach consistent with the principles of USP General Chapter <203>.

This assay quantifies E-guggulsterone and Z-guggulsterone, the key bioactive sterols in Commiphora mukul (guggul) resin. Using HPLC, it provides precise measurement of each isomer to verify extract potency, standardization levels, and compliance with product label claims.

Samples are extracted with an organic solvent (e.g., methanol or acetonitrile) and analyzed by HPLC with UV detection at a compound-specific wavelength (typically ~242 nm). Quantification is performed using certified E- and Z-guggulsterone standards, with internal standard correction and duplicate injections to ensure accuracy and reproducibility.

Results are reported in mg per g or % w/w for each isomer and total guggulsterones. Values are compared to standardized extract specifications (e.g., 2.5% guggulsterones) and label claims to confirm potency and detect adulteration or degradation.

This test quantifies harpagoside (8-O-p-coumaroylharpagide) — the principal iridoid glycoside bioactive constituent and primary standardization marker of devil's claw (Harpagophytum procumbens DC. ex Meissn. and H. zeyheri Decne.) — in raw materials, root extracts, and dietary supplements using High-Performance Liquid Chromatography (HPLC). Devil's claw is a well-established botanical used in dietary supplements and traditional medicine for the management of joint pain, osteoarthritis, and musculoskeletal discomfort, with harpagoside content serving as the key potency specification for standardized extracts. Accurate quantification is essential for verifying label claims, confirming compliance with pharmacopeial and industry specifications for harpagoside content, and ensuring batch-to-batch consistency of devil's claw raw materials. Results are reported as a percentage or in milligrams per gram or per serving.

A representative sample is accurately weighed and extracted using an appropriate aqueous-organic solvent system (e.g., aqueous methanol or ethanol) to ensure complete extraction of harpagoside and related iridoid glycosides. The extract is filtered and analyzed by reversed-phase HPLC on a C18 column with UV detection at 278 nm, the characteristic absorption maximum of harpagoside's p-coumaroyl ester chromophore. Quantification is performed against a multi-point external calibration curve prepared from a certified harpagoside reference standard. Where applicable, related iridoid glycosides — including harpagide and procumbide — may be monitored simultaneously to provide a broader iridoid profile. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

Harpagoside's p-coumaroyl ester chromophore provides strong UV absorption at 278 nm, making HPLC with UV detection a sensitive and specific method for its quantification without the need for derivatization. Chromatographic separation on a C18 column resolves harpagoside from related iridoid glycosides and matrix components present in devil's claw extracts, ensuring that potency results reflect harpagoside content specifically. This specificity is important for compliance with pharmacopeial specifications — harpagoside content is defined in the European Pharmacopoeia (Ph. Eur.) monograph for Harpagophytum root — and for label claim accuracy in the dietary supplement market. The method supports raw material qualification, finished product release testing, and cGMP compliance under 21 CFR 111.

This test quantifies hesperidin, a flavanone glycoside and the predominant bioactive polyphenol found in citrus peel and citrus-derived extracts, in dietary supplements and raw materials using High-Performance Liquid Chromatography with UV detection (HPLC-UV). Hesperidin is widely used in supplements for its studied effects on vascular integrity, circulation, and antioxidant activity, and its concentration serves as the primary potency and standardization marker for citrus bioflavonoid ingredients. Results are reported in mg per serving or as a percentage of extract weight to support label claim verification and cGMP compliance.

A representative sample is weighed and extracted using a methanol or ethanol-water solvent system with sonication or heating to ensure complete solubilization of hesperidin from the matrix. The extract is filtered, diluted to volume, and injected onto a reversed-phase C18 HPLC column. Detection is performed by UV at approximately 280–284 nm, and quantification is performed against a multi-point external calibration curve prepared from a certified hesperidin reference standard. System suitability and QC samples are run concurrently to confirm method accuracy and reproducibility across the analytical run.

Hesperidin is the primary bioactive marker used to define the potency of citrus bioflavonoid extracts, and accurate quantification is essential for verifying standardization levels and substantiating label claims. HPLC-UV provides the selectivity needed to resolve hesperidin from structurally related flavonoids — including narirutin, naringenin, and diosmin — that are commonly co-present in citrus extracts, ensuring reliable potency data for both raw material qualification and finished product release testing.

This assay measures hexanicotinate—often used as a “flush-free” niacin source—using High-Performance Liquid Chromatography (HPLC). The method provides accurate and selective quantification in raw materials and finished products to ensure correct dosing and product consistency.

Samples are extracted and analyzed under validated HPLC chromatographic conditions. Hexanicotinate is separated from other niacin derivatives and detected via UV or diode-array detection. Quantitation is performed using certified reference standards, with calibration curves and replicate injections confirming precision and accuracy.

Testing verifies label claims, supports standardized potency, and ensures batch-to-batch manufacturing consistency.

This test confirms the botanical identity of Holy Basil (Ocimum sanctum) in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic rosmarinic acid, ursolic acid, and eugenol fingerprint of the sample is compared against a certified Ocimum sanctum reference standard to confirm species authenticity and detect substitution with other Ocimum species or unrelated botanical materials. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using methanol or ethanol-water and applied alongside a certified Ocimum sanctum reference standard onto an HPTLC silica gel plate. The plate is developed in a validated solvent system, derivatized with anisaldehyde-sulfuric acid or natural products reagent, and the fingerprint is compared visually and by densitometric scanning to the reference standard in terms of Rf values, band positions, and color profile.

Holy Basil is subject to substitution with other Ocimum species — including common sweet basil (O. basilicum) — that share a similar appearance but differ significantly in their bioactive compound profile. HPTLC identity testing provides a defensible species-level confirmation, supporting supplier qualification and cGMP compliance under 21 CFR 111.

This test quantifies Huperzine A, a bioactive alkaloid, in raw materials, capsules, and finished products using High-Performance Liquid Chromatography (HPLC). Accurate measurement of Huperzine A ensures product quality and label accuracy. The method achieves detection limits suitable for trace-level quantification, typically reported in mg/g or ppm.

Samples are prepared by solvent extraction using methanol to isolate Huperzine A from the matrix. The extract is filtered and injected into an HPLC system equipped with a reversed-phase C18 column. Detection is performed using UV absorbance at 310 nm, where Huperzine A exhibits strong absorption. Quantification is achieved by comparing peak areas to a calibration curve constructed from certified Huperzine A reference standards. Method accuracy is verified through duplicate injections, spiked recovery tests, and inclusion of quality control samples.

Results are reported in µg/g (raw material) or µg/serving (finished products). Testing verifies standardized potency, ensures raw material authenticity, and supports product quality and consistency.

This assay quantifies hyaluronic acid (HA), a polysaccharide naturally present in connective tissues and widely used for hydration, elasticity, and joint health applications. Testing ensures ingredient authenticity and confirms standardized HA content in raw materials and finished products.

Samples are analyzed under validated laboratory conditions to determine total hyaluronic acid concentration. Certified reference materials and quality controls are used to ensure accurate and reproducible results.

Results are reported in mg/g (raw materials) or mg/serving (finished products). Testing verifies label claims, supports product consistency, and confirms the purity and potency of sodium hyaluronate-containing formulations.

This test quantifies hydroxycitric acid (HCA), the primary bioactive organic acid and standardization marker found in Garcinia cambogia fruit rind extract, in dietary supplements and raw materials using High-Performance Liquid Chromatography (HPLC). HCA is the key active compound responsible for the appetite-suppressing and fat metabolism effects attributed to Garcinia cambogia, and its concentration defines the potency and quality of the extract. Results are reported in mg per serving or as a percentage of extract weight to support label claim verification and cGMP compliance.

A representative sample is weighed and extracted using an aqueous or dilute acidic solvent system with sonication to ensure complete solubilization of HCA from the matrix. Due to HCA's poor UV absorbance, detection is typically performed using a refractive index (RI) detector or following derivatization to improve UV sensitivity, or alternatively via an evaporative light scattering detector (ELSD). The extract is filtered, diluted to volume, and injected onto a reversed-phase or ion-exchange HPLC column appropriate for polar organic acid analysis. Quantification is performed against a multi-point external calibration curve prepared from a certified HCA reference standard, with system suitability and QC samples run concurrently to confirm method performance.

HCA is the defining potency marker for Garcinia cambogia extract and is one of the most commonly label-claimed actives in weight management supplements, making accurate quantification essential for label claim substantiation and cGMP compliance. Its highly polar, low-UV-absorbing structure presents analytical challenges that require careful column and detector selection, and a validated HPLC method ensures reliable, reproducible results that can withstand regulatory scrutiny and third-party audit.

This assay quantifies hydroxyproline, a specific amino acid used as a marker for collagen content in food or tissue samples. Collagen plays a key role in the texture and nutritional profile of products like gelatin and meat, making its measurement vital for quality control and formulation verification.

Samples are hydrolyzed under controlled conditions to release hydroxyproline from collagen. The hydrolysate is filtered and injected into an HPLC system, where hydroxyproline is separated and detected (often via UV). Calibration with known standards and duplicate injections ensure that the method yields accurate and reproducible results.

Results are expressed in mg per unit weight. Higher hydroxyproline content indicates greater collagen presence, aligning with expected levels in products designed to be rich in collagen. Deviations can signal issues in raw material quality or processing efficiency.

This assay measures hypericin, a naphthodianthrone compound, using High-Performance Liquid Chromatography (HPLC). The method provides accurate and selective quantification for quality control and standardization purposes.

Samples are extracted and analyzed under validated HPLC chromatographic conditions. Hypericin is separated from structurally related compounds and detected via UV or diode-array detection. Quantitation is performed using certified reference standards, with calibration curves and replicate injections ensuring accuracy and reproducibility.

Testing verifies standardized potency, confirms label claims, and ensures batch-to-batch consistency.

This assay quantifies immunoglobulin A (IgA) using an ELISA specific for bovine or human IgA. It is commonly used in colostrum, dairy proteins, and immunonutrition products.

Samples are extracted and analyzed using a sandwich ELISA with IgA-specific antibodies. Results are determined against a certified standard curve with internal controls.

Results are reported in mg/g or mg per serving. Used to validate immune-related label claims and ingredient potency.

This assay quantifies Immunoglobulin G (IgG), the most abundant antibody isotype, in colostrum powders, bovine plasma fractions, and immunonutrition products. Using HPLC, it verifies IgG concentration to ensure potency, standardization, and compliance with label claims for immune health products.

Samples are prepared in buffered aqueous solution and analyzed by HPLC using size-exclusion or affinity chromatography, with UV detection at a protein-specific wavelength. Quantification is performed using certified IgG reference standards, with internal standard correction and duplicate injections for precision.

Results are reported in mg per g or per serving. Values are compared to specification targets and label claims to confirm IgG content, detect dilution, and ensure immunological activity across batches.

This test measures the concentration of immunoglobulin M (IgM), an important immune system protein, in dairy products and functional powders using a specific ELISA method. Accurate quantification of IgM helps ensure product quality and bioactivity. The assay provides results in micrograms per milliliter (µg/mL) with a detection limit suitable for low-level IgM detection in complex matrices.

Samples are prepared by extracting IgM into a buffered solution optimized for protein stability. The extract is analyzed using a sandwich ELISA, where monoclonal antibodies specific to IgM capture and detect the protein. Colorimetric detection is performed at 450 nm, and quantification is achieved via a calibration curve generated from known IgM standards. Each run includes duplicate sample measurements, quality control samples, and spike recovery tests to validate accuracy and precision.

Results are reported in mg/g or per serving. This confirms the presence of immune-active fractions in colostrum and dairy products.

This assay measures indole-3-carbinol (I3C), a bioactive compound derived from glucosinolate precursors in cruciferous vegetables. HPLC analysis provides accurate quantification of I3C in raw materials and finished formulations, ensuring proper dosing and product standardization.

Samples are extracted and analyzed under validated HPLC chromatographic conditions. I3C is separated from related indole derivatives and detected via UV or diode-array detection. Quantitation is performed against certified reference standards, with calibration curves and replicate injections ensuring accuracy and reproducibility.

Testing verifies standardized potency, supports label claims, and ensures quality consistency in nutraceutical products containing cruciferous-derived actives.

This assay measures inosine—a purine nucleoside involved in energy metabolism and ATP-related pathways—using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). The method provides high sensitivity and selectivity for accurate quantification in raw materials and finished formulations.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. Inosine is detected in multiple reaction monitoring (MRM) mode and quantified using certified reference standards. Internal calibration and quality control checks ensure precision, accuracy, and reproducibility.

Testing verifies label claims, confirms ingredient purity, and ensures consistent dosing in inosine-containing formulations.

This assay quantifies total inositol content—including the most bioactive isomer, myo-inositol—using LC-MS/MS. It is commonly used in supplements for hormonal health, fertility, and neurological support, and helps confirm potency in single-ingredient and blended formulations.

Samples are extracted in aqueous solution and analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed with certified inositol standards, internal standard correction, and duplicate injections to ensure accurate, reproducible results.

Results are reported in mg per g or per serving. Values are compared to declared label claims and formulation targets to verify dosing accuracy and detect adulteration or degradation.

This assay measures inositol hexanicotinate—an esterified form of niacin bound to inositol—using High-Performance Liquid Chromatography (HPLC). The method accurately quantifies the intact ester to ensure correct dosing and product standardization across raw materials and finished formulations.

Samples are extracted and analyzed under validated HPLC chromatographic conditions. Inositol hexanicotinate is separated from free niacin, niacinamide, and related esters and detected via UV or diode-array detection. Quantitation is performed using certified reference standards, with calibration curves and replicate injections ensuring accuracy and reproducibility.

Testing confirms label claims, ensures ingredient purity, and supports consistent manufacturing of niacin-based formulations.

This test confirms the identity of Irish sea moss (Chondrus crispus Stackhouse) in raw materials, dried thallus powders, extracts, and dietary supplements using High-Performance Thin-Layer Chromatography (HPTLC). Chondrus crispus, commonly known as Irish moss or carrageen moss, is a red macroalgae (Rhodophyta) native to the rocky Atlantic coastlines of Europe and North America, widely used in dietary supplements for its rich content of carrageenan-type sulfated polysaccharides, iodine, trace minerals, and bioactive pigments including phycoerythrin and carotenoids. HPTLC identity testing generates a characteristic chromatographic fingerprint that is compared against an authenticated C. crispus reference standard to confirm species identity and detect potential adulteration or substitution with other red algae species — particularly Eucheuma spp. and Kappaphycus spp., which are commonly sold as "sea moss" but are botanically and chemically distinct from authentic Chondrus crispus.

A representative sample is accurately weighed and extracted using an appropriate solvent system (e.g., methanol or aqueous ethanol) to capture the characteristic secondary metabolite and pigment profile of C. crispus, including phycoerythrin-derived chromophores, carotenoids, and phenolic compounds. The extract is applied alongside a certified C. crispus reference standard and, where applicable, potential adulterant extracts (e.g., Eucheuma cottonii, Kappaphycus alvarezii), onto an HPTLC silica gel plate using an automated sample applicator. The plate is developed in a validated solvent system optimized to resolve the characteristic marker compounds of C. crispus. After development, the plate is evaluated under white light and UV light at 254 nm and 366 nm, and may be further derivatized with an appropriate reagent for enhanced visualization of phenolic and pigment constituents. The resulting fingerprint pattern is compared visually and, where applicable, by densitometric analysis to the authenticated reference standard in accordance with established HPTLC identity testing guidelines.

The market for Irish sea moss supplements has grown rapidly, accompanied by widespread mislabeling and substitution of authentic Chondrus crispus with tropical red algae species — primarily Eucheuma and Kappaphycus species — that are botanically unrelated and differ significantly in their phytochemical composition, mineral content, and carrageenan type. HPTLC fingerprinting provides a holistic, multi-compound chromatographic identity confirmation that distinguishes authentic C. crispus from these common substitutes based on differences in their secondary metabolite and pigment profiles, enabling detection of adulteration that would not be apparent from visual inspection or mineral content testing alone. This method aligns with USP botanical identity testing guidelines and supports cGMP compliance under 21 CFR 111, ensuring that only correctly identified raw materials are used in finished products.

This test quantifies isodesmosine — a structural isomer of desmosine and, like desmosine, a crosslink amino acid found exclusively in mature elastin — in dietary supplements, protein hydrolysates, and raw materials using LC-MS/MS. Isodesmosine and desmosine are typically measured together as a pair to provide a comprehensive and highly specific measure of total elastin crosslink content. Because isodesmosine is biosynthetically unique to elastin, its quantification serves as an independent confirmation of elastin identity and potency alongside desmosine. Results are reported in micrograms per gram or per serving.

Sample preparation follows the same acid hydrolysis protocol as for desmosine, releasing isodesmosine from the crosslinked elastin matrix. An isotopically labeled internal standard is added to the hydrolysate prior to analysis. The sample is analyzed by reversed-phase LC-MS/MS with ESI in positive ion mode, with MRM transitions selected specifically for isodesmosine, which is chromatographically resolved from desmosine under the validated method conditions. Quantification is performed against a multi-point external calibration curve prepared from a certified isodesmosine reference standard. Desmosine and isodesmosine are typically quantified within the same analytical run for efficiency. Quality control samples are run concurrently to confirm method accuracy and precision.

Isodesmosine complements desmosine as a co-exclusive elastin crosslink marker, and measuring both compounds together provides a more complete and robust assessment of elastin content than either marker alone. The combined desmosine/isodesmosine measurement is the most analytically rigorous approach to elastin quantification and is well suited for high-value elastin ingredient qualification where definitive authentication is required. LC-MS/MS provides the sensitivity and selectivity needed to resolve and quantify both crosslink isomers in complex hydrolyzed protein matrices.

This panel measures total isothiocyanates using a cyclocondensation reaction followed by HPLC-UV detection. It is commonly used to assess bioactive compounds like sulforaphane in broccoli, kale, and other Brassica-based ingredients.

Samples are reacted with 1,2-benzenedithiol to form a measurable chromophore specific to isothiocyanate groups. The resulting derivative is separated and quantified using HPLC with UV detection. Certified standards and internal calibration curves are used, with duplicate runs to ensure precision.

Results are reported in µmol/g or mg per g. Values are compared to label claims or known reference ranges for Brassica extracts to confirm potency and ingredient quality.

This test quantifies L-3-aminoisobutyric acid (L-AIBA), a non-protein amino acid produced endogenously during thymine catabolism and released by skeletal muscle during exercise, in dietary supplements and raw materials using Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS). L-AIBA has been studied as an exercise mimetic with roles in stimulating fat oxidation and brown adipose tissue activity. LC-MS/MS is required for this analysis due to the structural similarity of L-AIBA to other small amino acids and its presence at low concentrations in complex supplement matrices. Results are reported in mg per serving or mg per gram to support label claim verification and cGMP compliance.

A representative sample is weighed and extracted using an aqueous acidic solvent or protein precipitation with acetonitrile to isolate L-AIBA from the matrix. The clarified extract is injected onto a reversed-phase or HILIC (Hydrophilic Interaction Liquid Chromatography) column coupled to a triple quadrupole mass spectrometer operating in positive ionization Multiple Reaction Monitoring (MRM) mode. Specific precursor-to-product ion transitions characteristic of L-AIBA are monitored for quantification and identity confirmation. Quantification is performed against a multi-point calibration curve prepared from a certified L-AIBA reference standard, with a stable isotope-labeled internal standard used to correct for matrix effects and ensure accurate recovery.

L-AIBA is a small, highly polar amino acid that co-elutes with structurally similar compounds under standard chromatographic conditions, making UV-based HPLC methods insufficient for reliable quantification. LC-MS/MS in MRM mode provides the molecular specificity required to unambiguously identify and accurately quantify L-AIBA in complex supplement matrices, supporting label claim substantiation for an emerging ingredient category where product differentiation depends on confirmed potency.

This assay quantifies lactase enzyme activity based on Acid Lactase Units (ALU), following the Food Chemicals Codex (FCC) method. It measures the ability of the lactase enzyme to hydrolyze lactose under acidic conditions, ensuring that products marketed for dairy digestion contain effective enzyme levels.

Samples are incubated with a lactose substrate at an acidic pH. The enzymatic reaction is monitored by measuring the amount of glucose released, which correlates with lactase activity. The method follows the FCC monograph for lactase (ALU definition). Duplicate runs and standard curves using reference enzyme preparations ensure precision and reproducibility.

Results are reported in ALU/g (Acid Lactase Units per gram). Values are assessed against label claims and formulation targets to confirm potency, detect degradation, and ensure consistency across production batches.

This assay measures lactoferrin concentration using an Enzyme-Linked Immunosorbent Assay (ELISA). The method provides high specificity and sensitivity for lactoferrin quantification across dairy-based and formulated supplement products.

Samples are diluted and incubated in microplate wells coated with lactoferrin-specific antibodies. Bound antigen is detected through enzyme-linked secondary antibodies, producing a colorimetric signal proportional to concentration. Quantification is performed against a standard curve generated from known lactoferrin concentrations.

Results are reported in µg/mL (liquids) or mg/g (solids). Testing verifies label claims, confirms ingredient purity, and supports consistency in milk-derived and nutritional formulations.

This assay quantifies lactoperoxidase (LPO), a naturally occurring antimicrobial enzyme found in bovine colostrum and dairy-based ingredients. Using a validated colorimetric method, it measures LPO activity to confirm bioactive content and support immune-related and oral health claims.

Samples are extracted in aqueous buffer, and enzyme activity is measured by monitoring the oxidation of a chromogenic substrate (e.g., ABTS or TMB) in the presence of hydrogen peroxide and thiocyanate. Absorbance is read spectrophotometrically and compared to an LPO activity standard curve.

Results are typically reported in units of activity per gram (U/g). Values are compared to specification targets and used to confirm ingredient identity, potency, and consistency in LPO-containing products.

This assay quantifies lactose, the disaccharide sugar found in milk and dairy-derived ingredients. Using LC-MS/MS, it measures lactose content in raw materials and finished products to verify nutrition label accuracy, confirm lactose levels in dairy formulations, and support “lactose-free” or “low-lactose” claims.

Samples are extracted in aqueous solution, then analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed using certified lactose standards, with internal standard correction and duplicate injections to ensure sensitivity, reproducibility, and accuracy.

Results are reported in g per 100 g, g per 100 mL, or per serving. Values are compared with label claims and formulation targets to confirm compliance, detect undeclared lactose, and ensure consumer safety for sensitive populations.

This assay quantifies L-arginine, a conditionally essential amino acid involved in nitric oxide synthesis and cardiovascular support. Using LC-MS/MS, it verifies L-arginine content in dietary supplements, functional beverages, and sports nutrition products to confirm label claims and ensure potency.

Samples are extracted in aqueous solution and analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed with certified L-arginine standards, applying internal standard correction and duplicate injections for precision and reproducibility.

Results are reported in mg per g or per serving. Values are compared to formulation targets and declared label claims to confirm dosing accuracy and detect any degradation or underformulation.

This assay measures L-Arginine Alpha-Ketoglutarate (AAKG), a salt formed from L-arginine and alpha-ketoglutaric acid, using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). The method provides high specificity and sensitivity for both components in complex pre-workout and amino acid formulations.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. AAKG is quantified by detecting the arginine and α-ketoglutarate moieties in multiple reaction monitoring (MRM) mode and calculating total AAKG content against certified reference standards. Internal calibration and quality controls ensure accurate and reproducible results.

Testing verifies label claims, supports formulation consistency, and ensures potency in nitric oxide–boosting and performance-focused products.

This assay measures L-Carnitine Fumarate using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). The method provides highly sensitive and selective quantification of the L-carnitine component while accounting for its fumarate salt form in raw materials and finished formulations.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. L-Carnitine is detected in multiple reaction monitoring (MRM) mode and quantified against certified reference standards. Internal calibration and QC checks ensure precision, accuracy, and reproducibility across matrices.

Testing confirms label claims, verifies raw material purity, and ensures consistent potency in carnitine-based formulations.

This assay measures L-Carnitine L-Tartrate (LCLT), a stabilized and highly bioavailable form of L-carnitine, using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). The method provides highly selective and sensitive quantification across raw materials and finished products.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. L-carnitine is detected via multiple reaction monitoring (MRM) and quantified against certified reference standards. Internal calibration and quality control checks ensure accurate and reproducible results.

Testing confirms label claims, verifies raw material purity, and supports consistency across carnitine-based performance formulations.

This assay measures L-Carnosine, a naturally occurring dipeptide composed of beta-alanine and L-histidine, using High-Performance Liquid Chromatography (HPLC). The method provides accurate quantification in raw materials and finished formulations to ensure correct dosing and product standardization.

Samples are extracted and analyzed under validated HPLC chromatographic conditions. L-Carnosine is separated from related amino acids and dipeptides and detected by UV or diode-array detection. Quantitation is performed against certified reference standards using calibration curves and replicate injections for accuracy and reproducibility.

Testing ensures label compliance, confirms purity, and supports consistent formulation in performance and longevity products.

This assay quantifies L-citrulline, a conditionally essential amino acid commonly used in pre-workouts and cardiovascular supplements for its role in nitric oxide production. Using HPLC, it verifies the potency of citrulline in finished products and detects degradation or substitution over time.

Samples are extracted in aqueous solution and filtered before analysis. The extract is analyzed by HPLC with detection at a compound-specific wavelength. Quantification is performed using certified L-citrulline standards, with internal standard correction and duplicate runs to ensure accuracy.

Results are reported in mg per g or per serving. Values are compared with label claims and formulation targets. Testing confirms the active dose and verifies product stability throughout shelf life.

This test quantifies L-citrulline — a non-essential amino acid that serves as a key precursor to L-arginine and nitric oxide in the urea cycle — in raw materials and dietary supplements using a titration-based assay. L-citrulline is widely used in sports nutrition and pre-workout formulations for its role in supporting vasodilation, blood flow, and exercise endurance. Titration provides a straightforward, reliable measure of L-citrulline purity and content, and is particularly well suited for high-purity raw material testing where the compound is present as the dominant analyte. Results are reported as a percentage purity or in milligrams per gram.

A representative sample is accurately weighed and dissolved in a suitable solvent such as glacial acetic acid or water, depending on the validated titration protocol. The sample is titrated against a standardized titrant — typically perchloric acid in glacial acetic acid for non-aqueous titration, or a standardized acid or base for aqueous potentiometric titration — using a calibrated burette or automated titrator. The endpoint is determined potentiometrically or by indicator color change, and the L-citrulline content is calculated from the volume and molarity of titrant consumed relative to the sample weight. Blank titrations and reference standard checks are performed concurrently to confirm method accuracy and standardized titrant concentration.

Titration is a well-established, pharmacopoeial-aligned method for determining the purity of amino acid raw materials, offering a direct measure of total titratable content without the need for chromatographic separation. For high-purity L-citrulline raw materials, titration provides a rapid and cost-effective means of confirming that the ingredient meets its declared purity specification prior to use in formulation. This method supports incoming raw material qualification and cGMP compliance under 21 CFR 111.

This assay measures L-Citrulline Malate using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS). The method provides highly selective and sensitive quantification of the citrulline component while accounting for its malate salt form in complex sports-nutrition formulations.

Samples are extracted and analyzed under validated LC-MS/MS chromatographic conditions. L-Citrulline is detected in multiple reaction monitoring (MRM) mode and quantified against certified reference standards. Internal calibration and QC checks ensure accuracy, precision, and reproducibility across matrices.

Testing verifies label claims, ensures purity, and confirms consistent potency in citrulline-based performance supplements.

This test measures the concentration of L-Cysteine, an important amino acid, in raw materials, powders, and finished products using High-Performance Liquid Chromatography (HPLC). Accurate quantification of L-Cysteine ensures product quality and compliance with formulation specifications. The method provides sensitive detection with reporting limits down to 0.1 mg/g.

Samples are first extracted with a phosphate buffer and then derivatized using o-phthalaldehyde (OPA) to enhance fluorescence detection. The derivatized samples are injected into an HPLC system equipped with a fluorescence detector set at excitation 340 nm and emission 450 nm. Separation is achieved on a reversed-phase C18 column using a gradient elution with a mobile phase of phosphate buffer and acetonitrile. Quantification is performed by comparing peak areas to a calibration curve prepared from certified L-Cysteine standards. Method accuracy is verified through duplicate injections, spike recovery tests, and inclusion of quality control samples.

Results are reported in mg/g (raw materials) or mg/serving (finished products). Testing verifies compliance with label claims, ensures product consistency, and confirms raw material purity.