This panel includes Total Plate Count, Yeast & Mold, Coliforms, E. coli, Salmonella, and Staphylococcus aureus. It provides a comprehensive screen for microbial load, spoilage organisms, and key pathogens to ensure product safety and compliance.

Samples are prepared and plated on selective and non-selective agar media appropriate for each organism. Incubation times and conditions follow USP, AOAC, and FDA BAM guidelines. Confirmatory biochemical or molecular methods are used where necessary for pathogen identification. All tests include appropriate controls and duplicate runs.

Results are reported in CFU/g or as Detected / Not Detected depending on the assay. Values are assessed against regulatory limits and industry standards (e.g., USP <2021>, <2022>, <2023>) to verify safety and microbial integrity.

This test detects and quantifies yeast and mold, common spoilage organisms in food and supplements that can affect shelf life and safety.

Samples are plated on selective agar and incubated to allow growth of yeasts and molds. Results are reported as CFU/g or CFU/mL.

Low levels indicate clean processing and storage. Elevated levels may lead to spoilage or product recalls.

This test confirms the botanical identity of Reishi mushroom (Ganoderma lucidum) in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic triterpenoid and polysaccharide fingerprint of the sample is compared against a certified Ganoderma lucidum reference standard to confirm species authenticity and detect substitution with other Ganoderma species or unrelated fungal 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 Ganoderma lucidum 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.

Reishi is among the most adulterated mushroom ingredients in the supplement market, with other Ganoderma species and mycelium-on-grain preparations frequently substituted for authentic fruiting body material. HPTLC identity testing provides a rapid and defensible species confirmation, supporting supplier qualification and cGMP compliance under 21 CFR 111.

This panel detects and quantifies residual solvents that may remain from manufacturing, extraction, or purification processes. Using GC-MS, it screens for Class 1, 2, and 3 solvents as defined by ICH Q3C guidelines to ensure product safety and compliance with FDA and USP requirements.

Samples are prepared using headspace or direct solvent extraction methods. The extract is analyzed by Gas Chromatography–Mass Spectrometry (GC-MS) using compound-specific retention times and mass spectral data. Quantification is performed using certified solvent standards and validated calibration curves. Internal standards and duplicate runs ensure accuracy.

Results are reported in ppm (mg/kg or µg/g). Values are compared with ICH Q3C limits based on solvent classification. This test ensures solvents are below acceptable daily exposure levels and helps validate purification processes in herbal extracts, pharmaceuticals, supplements, and cosmetics.

This test screens for and quantifies residual solvents — organic volatile impurities that may remain in raw materials, excipients, or finished products as a result of their manufacture or purification — across all three USP risk classes in accordance with USP General Chapter <467> (Residual Solvents). Class I solvents (e.g., benzene, carbon tetrachloride, 1,2-dichloroethane) are known or suspected human carcinogens and are subject to the strictest limits or should be avoided entirely. Class II solvents (e.g., acetonitrile, chloroform, methanol, toluene, hexane) are non-genotoxic animal carcinogens or possible causative agents of other irreversible toxicities, and are subject to defined permitted daily exposure (PDE) limits. Class III solvents (e.g., ethanol, ethyl acetate, isopropanol, acetone) have low toxic potential and are acceptable at higher levels. Residual solvent testing is critical for ensuring the safety of dietary supplement ingredients processed using organic solvents during extraction, purification, or synthesis. Results are reported in parts per million (ppm) for each solvent detected, compared against USP <467> limits.

A representative sample is accurately weighed and prepared using one or both of the sample preparation approaches specified in USP <467>: direct dissolution in a suitable solvent (Procedure A) or headspace preparation (Procedure B), in which the sample is dissolved or dispersed in an appropriate diluent in a sealed headspace vial and equilibrated at a controlled elevated temperature to partition residual volatile solvents into the headspace. The headspace gas or dissolved sample is analyzed by Gas Chromatography with Flame Ionization Detection (GC-FID) and/or Mass Spectrometry (GC-MS) using validated methods capable of resolving and quantifying all Class I, II, and III solvents included in the USP <467> panel. Quantification is performed against multi-point external calibration curves prepared from certified residual solvent reference standards, with an appropriate internal standard used for method performance verification. All results are compared against the concentration limits specified in USP <467> Tables 1, 2, and 3.

Residual solvent testing by USP <467> is the pharmacopeially recognized standard for organic volatile impurity control in pharmaceutical and dietary supplement ingredients, providing a structured, risk-based framework for evaluating solvent safety across all three toxicological classes. Headspace GC is the preferred technique for residual solvent analysis as it minimizes matrix interference by selectively partitioning volatile analytes into the gas phase, while GC-MS provides confirmatory identification of detected solvents. Comprehensive Class I, II, and III panel testing ensures that all solvent classes relevant to the manufacturing history of the ingredient are evaluated, supporting raw material qualification, finished product safety, and cGMP compliance under 21 CFR 111.

This assay quantifies resveratrol, a polyphenolic compound primarily found in grapes and Japanese knotweed. Using HPLC, it verifies resveratrol content in supplements, functional foods, and botanical extracts to confirm label claims and ensure consistent dosing in longevity and heart health formulations.

Samples are extracted using alcohol-based solvents under light-protected conditions and analyzed by HPLC with UV detection at a compound-specific wavelength. Quantification is performed using certified resveratrol standards, with internal standard correction and duplicate injections to ensure accuracy.

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

This test confirms the botanical identity of Rhodiola rosea in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic rosavins and salidroside fingerprint of the sample is compared against a certified Rhodiola rosea reference standard to confirm species authenticity and detect substitution with other Rhodiola species — such as R. crenulata — that lack the rosavin compounds unique to R. rosea. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using methanol or ethanol-water and applied alongside a certified Rhodiola rosea 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.

Rhodiola rosea is one of the most commonly adulterated adaptogens, with R. crenulata — which contains salidroside but not rosavins — frequently substituted due to its lower cost. HPTLC identity testing is the most practical method for distinguishing R. rosea from other Rhodiola species based on the presence of species-specific rosavin compounds, supporting supplier qualification and cGMP compliance under 21 CFR 111.

This test confirms the identity of Chinese rhubarb (Rheum palmatum L., and related pharmacopeial species including R. officinale and R. tanguticum) in raw materials, root powders, extracts, and dietary supplements using High-Performance Thin-Layer Chromatography (HPTLC). Rheum palmatum, commonly known as Chinese or medicinal rhubarb, is a well-established botanical used in traditional Chinese medicine and Western herbal practice for its role in supporting digestive function, bowel regularity, and gastrointestinal health. Its characteristic phytochemical profile includes anthraquinone glycosides and aglycones (emodin, rhein, aloe-emodin, chrysophanol, physcion), stilbene glycosides (rhaponticin), and tannins. HPTLC identity testing generates a characteristic chromatographic fingerprint that is compared against an authenticated R. palmatum reference standard to confirm species identity and detect potential adulteration, substitution with common garden rhubarb (R. rhabarbarum or R. rhaponticum) — which lacks the pharmacopeial anthraquinone profile — or blending with other anthraquinone-containing botanicals.

A representative sample is accurately weighed and extracted using an appropriate solvent system (e.g., methanol or aqueous ethanol) to capture the characteristic anthraquinone and stilbene profile of R. palmatum. The extract is applied alongside a certified R. palmatum reference standard and, where applicable, potential adulterant extracts (e.g., R. rhabarbarum, Rumex species), 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 anthraquinone aglycones and glycosides of R. palmatum. After development, the plate is evaluated under UV light at 254 nm and 366 nm — where anthraquinones display characteristic fluorescence — and may be further derivatized with potassium hydroxide solution or anisaldehyde-sulfuric acid reagent for enhanced visualization under white light. 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.

Medicinal rhubarb (R. palmatum and related pharmacopeial species) is subject to adulteration and substitution with common garden rhubarb (R. rhabarbarum), which is morphologically similar but lacks the characteristic anthraquinone glycoside profile required for pharmacopeial compliance and the associated biological activity. HPTLC fingerprinting provides a holistic, multi-compound chromatographic identity confirmation — anchored by the characteristic anthraquinone pattern — that is more discriminating than single-marker assays and enables detection of substitution or adulteration that would not be apparent from potency testing alone. This method aligns with USP and European Pharmacopoeia (Ph. Eur.) 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 quantifies total alpha-lipoic acid (ALA) in supplements and raw materials using LC-MS/MS. It does not distinguish between the R- and S-enantiomers, but instead measures total ALA content to verify label claims, confirm potency, and ensure product consistency.

Samples are extracted with organic solvents and analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed against certified alpha-lipoic acid standards, with internal standard correction and duplicate injections to ensure accuracy and reproducibility.

Results are reported in mg per g or per serving as total ALA. Values are compared to formulation targets and label claims to confirm dosing accuracy, detect underformulation, and verify product stability.

This assay quantifies rosavin, a key bioactive compound in Rhodiola rosea known for its adaptogenic and anti-fatigue properties. Using HPLC, it verifies rosavin content in botanical extracts and supplements to ensure proper standardization and support claims related to mood, energy, and stress modulation.

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

Results are reported in mg per g or per serving. Values are compared to label claims and standardization targets to confirm consistency in Rhodiola extracts and detect low-quality or adulterated material.

This test quantifies rosmarinic acid, a naturally occurring hydroxycinnamic acid ester and the primary water-soluble polyphenol found in rosemary, sage, lemon balm, and other Lamiaceae herbs, in dietary supplements and raw materials using High-Performance Liquid Chromatography with UV detection (HPLC-UV). Rosmarinic acid is a key bioactive marker and standardization compound for these botanical extracts, valued for its antioxidant, anti-inflammatory, and neuroprotective properties. 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 to ensure complete recovery of rosmarinic acid from the botanical matrix. The extract is filtered, diluted to volume, and injected onto a reversed-phase C18 HPLC column. Detection is performed by UV at approximately 330 nm, corresponding to the characteristic absorbance of the hydroxycinnamic acid chromophore, and quantification is performed against a multi-point external calibration curve prepared from a certified rosmarinic acid reference standard. System suitability and QC samples are run concurrently to confirm method accuracy and reproducibility across the analytical run.

Rosmarinic acid is the primary standardization marker for lemon balm, rosemary, and related Lamiaceae extracts, and its accurate quantification is essential for verifying extract potency and label claim compliance. HPLC-UV at 330 nm provides the selectivity needed to resolve rosmarinic acid from co-present phenolic acids — including caffeic acid and salvianolic acids — in complex botanical matrices, delivering reliable potency data for both raw material qualification and finished product release testing.

This test quantifies rutin, a bioactive flavonoid glycoside of quercetin, in raw materials, powders, and finished botanical products. Using Liquid Chromatography–Tandem Mass Spectrometry (LC-MS/MS), the method achieves sensitive and specific detection with a reporting limit as low as 0.1 mg/kg. Accurate rutin measurement supports quality control and standardization of herbal supplements and nutraceuticals.

Samples are extracted with 70% methanol under sonication to release rutin from the matrix. The extract is filtered and injected into an LC-MS/MS system operating in Multiple Reaction Monitoring (MRM) mode, targeting rutin-specific precursor and product ions. Quantification is performed using a calibration curve constructed from certified rutin reference standards, with an isotopically labeled internal standard to correct for matrix effects. Method accuracy is verified through duplicate injections, spiked recovery tests, and quality control samples analyzed alongside each batch.

Results are reported in mg/g (raw material) or mg/serving (finished products). Testing confirms standardized potency in plant extracts, verifies label claims, and supports quality control for flavonoid-rich formulations.

This assay quantifies S-adenosyl-L-methionine (SAMe), a bioactive methyl donor involved in neurotransmitter synthesis, detoxification, and joint support. Using LC-MS/MS, it verifies SAMe content in supplements and functional formulas to ensure label accuracy and product stability.

Samples are extracted under acid-stabilized, light-protected conditions to prevent degradation. The extract is analyzed by LC-MS/MS using compound-specific mass transitions. Quantification is performed using certified SAMe standards, with internal standard correction and duplicate runs to ensure precision.

Results are reported in mg per g or per serving. Values are compared to formulation targets and declared label claims. Testing confirms bioactive content and helps detect instability due to SAMe’s known sensitivity to heat, moisture, and pH.

This assay quantifies safranal, a volatile compound and key bioactive in saffron (Crocus sativus) linked to mood and neurological support. Using HPLC, it measures safranal content in saffron extracts and supplements to verify label claims and ensure consistent dosing in mood, vision, and cognitive health products.

Samples are extracted using alcohol-based solvents under light-protected conditions, then analyzed by HPLC with UV detection at a safranal-specific wavelength. Quantification is performed using certified safranal standards, with internal standard correction and duplicate runs for precision.

Results are reported in mg per g or per serving. Values are compared to formulation targets and standardization benchmarks to confirm potency and detect variability due to degradation or poor-quality raw material.

This assay quantifies salidroside, a key adaptogenic glycoside found in Rhodiola rosea. Using HPLC, it measures salidroside content in botanical extracts and supplements to verify standardization and support health claims related to mood, focus, and fatigue reduction.

Samples are extracted using water or alcohol-based solvents, then analyzed by HPLC with UV detection at a compound-specific wavelength. Quantification is performed using certified salidroside standards, with internal standard correction and duplicate runs to ensure accuracy.

Results are reported in mg per g or per serving. Values are compared to label claims and formulation targets to confirm consistent potency and detect variability in raw material or extract quality.

This assay detects Salmonella, a pathogenic bacteria that can cause severe foodborne illness.

Enrichment followed by plating on selective media and confirmation through biochemical or PCR testing. Reported as presence/absence per 25g.

Salmonella must be absent to ensure product safety and compliance.

This test quantifies selenium, an essential trace mineral and critical component of selenoproteins involved in antioxidant defense, thyroid hormone metabolism, and immune regulation, in dietary supplements, food products, and raw materials using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Selenium has a narrow margin between adequate intake and toxicity, making accurate quantification important for both label claim verification and safety assessment. Results are reported in µg per serving or µg per gram to support cGMP compliance and regulatory requirements.

A representative sample is digested using microwave-assisted acid digestion with a nitric acid and hydrogen peroxide mixture to fully dissolve the matrix and bring all selenium into solution. The digested solution is diluted to volume and analyzed by ICP-MS using collision/reaction cell technology to minimize polyatomic spectral interferences — particularly from argon-based and chloride-based ions that overlap with selenium isotopes. Quantification is performed against a multi-point external calibration curve prepared from a certified selenium reference standard, with an appropriate internal standard used to correct for matrix effects and instrument drift. Certified reference materials and method blanks are run concurrently to confirm accuracy and recovery.

Selenium presents significant analytical challenges by ICP-MS due to polyatomic interferences on its primary isotopes from argon dimers, argon chloride, and other matrix-derived species, requiring collision/reaction cell technology or careful isotope selection for accurate measurement. Given selenium's narrow therapeutic window — with the tolerable upper intake level set at just 400 µg/day for adults — precise quantification is essential not only for label claim compliance but also for ensuring product safety, particularly in high-dose selenium supplements and selenium-enriched yeast ingredients.

This assay detects sesame proteins in food products using an immunoassay format. Sesame is a potent allergen, so accurate detection is critical for verifying allergen claims and preventing cross-contact in production facilities.

Samples are extracted in a buffer optimized for protein recovery and applied to ELISA plates coated with sesame-specific antibodies. After incubation and multiple wash cycles, a secondary enzyme-linked antibody is added and a colorimetric reaction is developed. The absorbance is compared to a calibration curve constructed with sesame protein standards, with replicates and controls ensuring precision.

Results are expressed in ppm of sesame protein. Non-detectable values confirm that the product is free from sesame, while any measurable level indicates possible contamination, prompting review of allergen control measures.

This assay detects allergenic proteins from shellfish and crustaceans in food products. It is critical for ensuring that products labeled as free from these allergens do not contain cross-contact, protecting sensitive consumers from potentially severe allergic reactions.

Samples are extracted using an appropriate buffer and applied to ELISA plates pre-coated with antibodies specific to shellfish allergens. Following incubation and thorough washing, a secondary enzyme-linked antibody is added. The resulting colorimetric change is measured and compared against a calibration curve, with duplicate tests and controls confirming the assay’s reliability.

Results are reported in ppm of allergenic protein. A non-detect result supports a “free from” claim, while any measurable level requires corrective action in processing or labeling to ensure consumer safety.

This assay screens for the presence of Shiga-toxin producing Escherichia coli. STEC strains produce Shiga toxins (Stx1, Stx2) that can cause gastrointestinal illness and complications such as hemolytic uremic syndrome (HUS). Testing is critical for high-risk foods such as leafy greens, sprouts, ground meats, and ready-to-eat products.

Samples are enriched and analyzed using validated microbiological methods (culture, PCR, or immunoassay-based) to detect E. coli strains carrying Shiga-toxin genes. Confirmatory testing differentiates pathogenic STEC from non-pathogenic E. coli.

Results are reported qualitatively as “Not Detected” or “Detected.” Testing ensures compliance with FDA/USDA guidelines, verifies food safety, and protects against outbreaks.

This assay screens samples for the presence of Shigella species, pathogenic bacteria associated with foodborne illness. Detection of Shigella is critical for assessing safety in foods, supplements, and raw materials.

Samples are analyzed using validated microbiological screening techniques appropriate for the sample matrix. Controls and confirmatory steps are applied as needed to ensure reliable detection.

Results are reported qualitatively as Detected or Not Detected. Testing supports food safety programs, regulatory compliance, and contamination risk assessment.

This test confirms the identity of shilajit — a mineral-rich exudate from Himalayan and Altai mountain rock formations — in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic fulvic acid and dibenzo-alpha-pyrone (DBP) compound fingerprint of the sample is compared against a certified shilajit reference standard to confirm authenticity and detect adulteration with synthetic fulvic acid, humic acid, or other substitutes. Results are reported as confirmed identity or non-conforming.

A representative sample is dissolved in methanol or water and applied alongside a certified shilajit reference standard onto an HPTLC silica gel plate. The plate is developed in a validated solvent system and examined under UV light (254 nm and 366 nm) and after derivatization with an appropriate reagent. The resulting fingerprint is compared visually and by densitometric scanning to the reference standard in terms of Rf values, band positions, and fluorescence profile.

Shilajit is a high-value ingredient with a significant risk of adulteration, particularly with synthetic fulvic acid or humic acid preparations that mimic its appearance but lack its full bioactive compound profile. HPTLC identity testing provides a practical and defensible method for confirming authenticity, supporting supplier qualification and cGMP compliance under 21 CFR 111.

This test quantifies elemental silicon in raw materials, botanical extracts, and dietary supplements using Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). Silicon is the second most abundant element in the Earth's crust and is present in dietary supplements primarily as orthosilicic acid, silicon dioxide (silica), or plant-derived silica from sources such as horsetail (Equisetum arvense) and bamboo extract. Silicon is increasingly recognized as a nutritionally relevant trace element with roles in bone mineralization, collagen synthesis, and the structural integrity of connective tissue, skin, hair, and nails. ICP-OES provides the sensitivity, precision, and multi-element capability required to accurately quantify silicon across a wide range of concentrations in complex botanical and mineral matrices. Results are reported in milligrams of elemental silicon per gram or per serving.

A representative sample is accurately weighed and subjected to complete acid digestion using a validated microwave-assisted or fusion-based digestion procedure. Silicon presents unique digestion challenges due to the high chemical inertness of silica (SiO₂); accordingly, digestion protocols typically employ hydrofluoric acid (HF) in combination with nitric acid, or alkaline fusion with sodium hydroxide or lithium metaborate/tetraborate, to ensure complete dissolution of siliceous materials. The digested solution is diluted to volume with ultrapure water and analyzed by ICP-OES, monitoring silicon at an appropriate emission line (e.g., 251.611 nm or 212.412 nm) selected to minimize spectral interferences. An appropriate internal standard is used to correct for matrix effects and instrument drift. Quantification is performed against a multi-point external calibration curve prepared from a certified silicon reference standard traceable to NIST. Certified reference materials and method blanks are analyzed concurrently to confirm digestion efficiency, accuracy, and precision.

Silicon quantification requires careful attention to sample digestion, as silicon dioxide is among the most chemically resistant inorganic compounds and is incompletely dissolved by standard nitric acid digestion alone. ICP-OES with appropriate digestion (HF-based or fusion) provides the complete dissolution and sensitive, accurate elemental detection needed to reliably quantify silicon across the concentration ranges relevant to dietary supplements and botanical ingredients. ICP-OES is preferred over ICP-MS for silicon due to polyatomic spectral interferences at the primary silicon isotope masses in ICP-MS, making optical emission the more practical and robust technique for routine silicon analysis. This method supports label claim substantiation, raw material qualification, and cGMP compliance under 21 CFR 111.

This test quantifies silicon (Si), expressed as silicon dioxide (SiO₂), in dietary supplements, food products, and raw materials using Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). Silicon dioxide is widely used in the supplement and food industry as an anti-caking agent and flow aid, and is also present as a functional ingredient in certain bone and connective tissue health formulations. Accurate quantification is important for verifying that silicon dioxide levels are within permitted use limits as a food additive, or for confirming the declared silicon content in functional silica-based ingredients. Results are reported as a percentage or in milligrams per gram, expressed as SiO₂ or elemental silicon as applicable.

A representative sample is digested using a validated high-temperature fusion or alkaline digestion protocol — such as sodium peroxide or sodium hydroxide fusion — or microwave-assisted acid digestion with hydrofluoric acid, as standard nitric acid digestion alone is insufficient for complete dissolution of silica. The resulting digest is diluted to volume with ultrapure water and analyzed by ICP-OES, with silicon quantified at its characteristic emission wavelength (typically 251.6 nm or 212.4 nm). Quantification is performed against a multi-point external calibration curve prepared from a certified silicon reference standard. An internal standard is used to correct for matrix effects and instrument drift, and certified reference materials and method blanks are analyzed concurrently to confirm accuracy and monitor for contamination.

Silicon dioxide is one of the most commonly used excipients in dietary supplement manufacturing, and its accurate quantification is important for confirming compliance with FDA-permitted use levels as a food additive (21 CFR 172.480) and for verifying the silicon content of functional silica ingredients. ICP-OES is the preferred method for silicon quantification due to its high sensitivity, wide linear dynamic range, and ability to handle the specialized digestion conditions required for complete silica dissolution. Accurate silicon analysis supports both excipient quality control and functional ingredient potency verification under 21 CFR 111.