This test quantifies L-methyltetrahydrofolic acid (5-MTHF), the active, bioavailable form of Vitamin B9 (folate), in dietary supplements and raw materials using High-Performance Liquid Chromatography with UV detection (HPLC-UV). Unlike synthetic folic acid, 5-MTHF does not require enzymatic conversion and is the predominant circulating form of folate in the body, making accurate potency measurement critical for products targeting methylation support, prenatal health, and cardiovascular function. Results are reported in mcg per serving or mcg per gram to support label claim verification and cGMP compliance.

A representative sample is weighed and extracted using a dilute phosphate buffer or acidic aqueous solvent under low-light conditions to minimize photodegradation of the folate compound. The extract is filtered, diluted to volume, and injected onto a reversed-phase C18 HPLC column. Detection is performed by UV at approximately 290–300 nm, and quantification is performed against a multi-point external calibration curve prepared from a certified 5-MTHF reference standard. System suitability and QC samples are run concurrently, and all sample preparation steps are conducted under amber or reduced-light conditions to preserve analyte integrity.

5-MTHF is increasingly used in premium supplement formulations as a bioavailable alternative to synthetic folic acid, particularly for individuals with MTHFR gene variants who have reduced capacity to convert folic acid to its active form. Accurate quantification of 5-MTHF is essential to substantiate label claims, differentiate it from other folate forms in multi-ingredient products, and meet FDA cGMP requirements. HPLC-UV provides the specificity and sensitivity required to measure this light-sensitive compound reliably across capsule, tablet, and powder matrices.

This test quantifies ascorbic acid (Vitamin C) in dietary supplements, fortified foods, beverages, and raw materials using High-Performance Liquid Chromatography with UV detection (HPLC-UV). Vitamin C is one of the most widely used dietary supplement ingredients and is essential for immune defense, collagen synthesis, and antioxidant activity. 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 a dilute acidic solvent — typically metaphosphoric acid or oxalic acid solution — to stabilize ascorbic acid and prevent oxidative degradation during sample preparation. The extract is filtered, diluted to volume, and injected onto a reversed-phase C18 HPLC column. Detection is performed by UV at approximately 245–254 nm, and quantification is performed against a multi-point external calibration curve prepared from a certified ascorbic acid reference standard. System suitability and QC samples are run concurrently to confirm method accuracy and stability of the analyte throughout the analytical run.

Vitamin C is a required nutrient declaration on supplement facts panels and is among the most commonly label-claimed ingredients in the supplement industry. Accurate potency measurement is essential for regulatory compliance and consumer trust. HPLC-UV is preferred over titration methods for complex matrices because it provides the selectivity to distinguish ascorbic acid from interfering reducing agents and co-formulants, delivering reliable results across tablets, capsules, powders, and liquids.

This test quantifies the vitamin C content of calcium ascorbate — a calcium salt of ascorbic acid commonly used as a buffered, stomach-friendly alternative to ascorbic acid in dietary supplements — by measuring its ascorbic acid equivalent content using High-Performance Liquid Chromatography (HPLC). Calcium ascorbate contains approximately 89–91% ascorbic acid by mass (theoretical), and potency is reported as ascorbic acid equivalents to align with standard vitamin C label claim conventions under 21 CFR 101. Accurate quantification ensures that the declared vitamin C content is present and supports compliance with nutritional labeling requirements and cGMP standards under 21 CFR 111. Results are reported in milligrams of ascorbic acid equivalents per gram or per serving.

A representative sample is accurately weighed and dissolved in an appropriate aqueous diluent, typically a dilute acidic solution (e.g., metaphosphoric acid or oxalic acid) to stabilize ascorbic acid and prevent oxidative degradation during sample preparation. The solution is filtered and analyzed by reversed-phase HPLC on a C18 column with UV detection at 254 nm, the characteristic absorption maximum of ascorbic acid. Quantification is performed against a multi-point external calibration curve prepared from a certified L-ascorbic acid reference standard. Both L-ascorbic acid and, where applicable, dehydroascorbic acid (the oxidized form) may be monitored to assess total vitamin C activity. Quality control samples are run concurrently to confirm method accuracy, precision, and linearity throughout the analytical run.

While calcium ascorbate can be characterized by titration or colorimetric methods, HPLC with UV detection provides superior specificity by chromatographically resolving ascorbic acid from potential degradation products, excipients, and matrix interferences. This is particularly important for finished supplement matrices where other antioxidants or reducing agents may interfere with non-specific assay methods. Reporting results as ascorbic acid equivalents ensures direct comparability with label claims and regulatory requirements for vitamin C content, supporting both raw material qualification and finished product release testing.

This test quantifies Vitamin D2 (ergocalciferol), an essential nutrient commonly added to dietary supplements and fortified foods, using LC-MS/MS for precise measurement. It is suitable for various matrices including raw materials, capsules, and powders. The method detects Vitamin D2 at concentrations as low as 1 ng/g, ensuring accurate assessment of product potency and compliance with labeling requirements.

Samples are first saponified with ethanolic potassium hydroxide to release ergocalciferol, followed by extraction with hexane. The extract is evaporated and reconstituted in methanol before analysis. LC-MS/MS is performed using electrospray ionization in positive mode, with multiple reaction monitoring (MRM) transitions specific to ergocalciferol. Quantification is achieved via an external calibration curve prepared from certified Vitamin D2 standards. Method accuracy and precision are verified through duplicate injections, spiked recovery tests, and inclusion of quality control samples in each batch.

Testing confirms label claims, ensures formulation accuracy, and supports regulatory compliance for Vitamin D–fortified products.

This test quantifies cholecalciferol (Vitamin D3) in dietary supplements, fortified foods, and raw materials using High-Performance Liquid Chromatography with UV detection (HPLC-UV). Vitamin D3 is the preferred supplemental form of Vitamin D due to its superior bioavailability and potency relative to Vitamin D2, and it plays a critical role in calcium absorption, bone mineralization, and immune regulation. Results are reported in IU or mcg per serving or per gram to support label claim verification and cGMP compliance.

A representative sample is weighed and subjected to saponification using an ethanolic potassium hydroxide solution under heat to release cholecalciferol from its matrix, followed by liquid-liquid extraction with an organic solvent such as hexane or diethyl ether. The extract is evaporated, reconstituted in mobile phase, and injected onto a normal-phase or reversed-phase HPLC column. Detection is performed by UV at approximately 265 nm, and quantification is performed against a multi-point external calibration curve prepared from a certified cholecalciferol reference standard. All sample preparation steps are conducted under amber or reduced-light conditions to prevent photodegradation, and system suitability and QC samples are run concurrently to confirm method performance.

Vitamin D3 is one of the most widely consumed dietary supplement ingredients and is subject to strict label claim requirements under FDA cGMP regulations. Accurate potency measurement is essential given the narrow therapeutic window between adequate intake and potential toxicity at high doses. HPLC-UV provides the selectivity to distinguish cholecalciferol from Vitamin D2 and related sterols in complex supplement matrices, ensuring reliable quantification across softgels, tablets, powders, and oil-based formulations.

This assay quantifies alpha-tocopherol, the most active and bioavailable form of vitamin E, in food and supplement samples. It measures vitamin E content using HPLC to ensure accurate dosing and verify label claims in antioxidant-focused formulations.

Samples are extracted under light- and oxygen-protected conditions to prevent oxidation. The extract is analyzed by HPLC with detection based on absorbance at a specific wavelength. Calibration with high-purity alpha-tocopherol standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in IU or mg per 100 g or per serving. The values are compared with formulation targets and label claims. Stable values confirm proper formulation and storage, while significant loss may indicate degradation due to oxidative stress.

This assay quantifies alpha-tocopherol acetate, a stabilized ester form of vitamin E, in food, supplement, and cosmetic samples. It measures vitamin E acetate content using HPLC to verify potency and ensure accurate dosing in formulations requiring oxidative stability.

Samples are extracted under light- and oxygen-protected conditions to preserve the ester structure. The extract is analyzed by HPLC with detection based on absorbance at a specific wavelength. Calibration with high-purity alpha-tocopherol acetate standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in IU or mg per 100 g or per serving. The values are compared with formulation targets and label claims. Stable values confirm ingredient integrity and resistance to oxidation, while loss may suggest hydrolysis or improper storage.

This assay quantifies alpha-tocopheryl succinate, a stable esterified form of vitamin E, in food and supplement samples. It measures vitamin E content using HPLC to ensure accurate dosing in formulations focused on oxidative stress and cellular defense.

Samples are extracted under light- and oxygen-protected conditions to preserve the ester form. The extract is analyzed by HPLC with detection based on absorbance at a specific wavelength. Calibration with high-purity alpha-tocopheryl succinate standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in IU or mg per 100 g or per serving. The values are compared with formulation targets and label claims. Consistent levels confirm ingredient stability and proper delivery, while loss may suggest hydrolysis or degradation over time.

This assay quantifies mixed tocopherols—typically including alpha-, beta-, gamma-, and delta-tocopherol—in food and supplement samples. It measures the individual tocopherol components using HPLC to ensure balanced formulation and support full-spectrum vitamin E labeling.

Samples are extracted under light- and oxygen-controlled conditions to protect all tocopherol forms. The extract is analyzed by HPLC with separation and detection of each tocopherol based on its unique absorbance. Calibration with individual high-purity tocopherol standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in mg per 100 g or per serving for each tocopherol component. Values are assessed individually and in total against formulation targets and label claims. This panel helps confirm tocopherol balance and stability across batches, while any imbalances may indicate degradation or formulation drift.

This assay quantifies vitamin K1—also known as phylloquinone or phytonadione—in food and supplement samples. It measures vitamin K1 content using HPLC to ensure accurate dosing and verify label claims in formulations supporting cardiovascular and skeletal health.

Samples are extracted under light- and oxygen-protected conditions to preserve the sensitive K1 molecule. The extract is analyzed by HPLC with detection based on absorbance at a specific wavelength. Calibration with high-purity phylloquinone standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in mcg per 100 g or per serving. Values are compared with formulation targets and label claims. Consistent results confirm ingredient stability, while variation may reflect degradation due to light, pH, or improper handling.

This assay quantifies menaquinone-4 (MK-4), a short-chain form of vitamin K2, in food and supplement samples. It measures MK-4 content using HPLC to verify label claims and ensure potency in formulations designed to support skeletal and cardiovascular health.

Samples are extracted under light- and oxygen-protected conditions to prevent MK-4 degradation. The extract is analyzed by HPLC with detection based on absorbance at a specific wavelength. Calibration with high-purity MK-4 standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in mcg per 100 g or per serving. The values are compared with formulation targets and label claims. Consistent results confirm ingredient stability and bioactive dosing, while variability may indicate oxidation or instability during storage or processing.

This assay quantifies menaquinone-7 (MK-7), a long-chain and highly bioavailable form of vitamin K2, in food and supplement samples. It measures MK-7 content using HPLC to verify potency and ensure extended-action support in bone and vascular formulations.

Samples are extracted under light- and oxygen-controlled conditions to protect MK-7 from degradation. The extract is analyzed by HPLC with detection based on absorbance at a specific wavelength. Calibration with high-purity MK-7 standards, along with internal standard correction and duplicate runs, ensures reliable quantification.

Results are provided in mcg per 100 g or per serving. The values are compared with formulation targets and label claims. Stable results confirm ingredient preservation and sustained-release potential, while degradation may suggest sensitivity to light, pH, or improper storage.

This assay detects and quantifies walnut and pecan proteins using a combined ELISA (Enzyme-Linked Immunosorbent Assay) validated for both tree nuts. It confirms the presence or absence of walnut or pecan contamination in raw materials, finished products, or manufacturing environments—critical for verifying allergen-free claims and meeting FDA labeling requirements.

Samples are extracted in a validated buffer and tested using a dual-reactive sandwich ELISA designed to detect both walnut and pecan proteins. Colorimetric detection is used, with results compared against certified standard curves. Controls and duplicate wells are used to ensure test accuracy.

Results are reported in ppm (mg/kg) for combined walnut and pecan protein. The assay typically detects trace levels down to 1–5 ppm, making it suitable for allergen screening in high-sensitivity applications.

This assay measures water activity (aw), which indicates the amount of free, unbound water in a product that is available to support microbial growth and chemical reactions. Water activity is expressed on a scale from 0.00 to 1.00, with higher values indicating greater potential for microbial activity. It is a key parameter for predicting shelf stability and safety in foods, supplements, and other consumable products.

Samples are placed in a sealed measurement chamber and analyzed using a calibrated water activity meter. The device determines the equilibrium relative humidity of the air surrounding the sample, which is converted into the aw value. The method follows AOAC, ISO, or ASTM guidelines for water activity

Results are reported as a unitless aw value (e.g., 0.35).

This assay detects wheat (Triticum aestivum) DNA using PCR (Polymerase Chain Reaction). It is used to confirm the presence or absence of wheat in raw materials, extracts, and processed products—ideal for verifying ingredient identity and detecting trace wheat contamination in gluten-sensitive or allergen-controlled applications.

DNA is extracted from the sample and amplified using wheat-specific primers. PCR analysis confirms wheat DNA presence through endpoint or real-time detection. Positive and negative controls are included to ensure accuracy and avoid false results.

Results are reported as Detected / Not Detected. This method can identify wheat DNA at trace levels, even in processed or refined products, making it ideal for compliance with gluten-free and wheat-free claims.

This assay quantifies withanolide glycosides, the primary bioactive compounds in Ashwagandha (Withania somnifera). Using HPLC, it provides a quantitative profile of withanolides to verify standardization in root or extract-based formulations and support label claims for stress, hormone, and energy balance.

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

Results are reported in mg per g or per serving, typically as total withanolides. Values are assessed against formulation targets and declared standardization levels (e.g., 5% or 10% withanolides) to confirm potency and detect adulteration or low-quality sourcing.

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 assay quantifies zeaxanthin, a key dietary carotenoid concentrated in the retina and often combined with lutein in vision-support supplements. Using HPLC, it measures zeaxanthin content in raw materials and finished products to confirm label claims, ensure potency, and maintain ingredient quality.

Samples are extracted using organic solvents (typically ethanol or hexane-based), then analyzed by HPLC with UV-Vis detection at a carotenoid-specific wavelength (typically ~450 nm). Quantification is performed using certified zeaxanthin standards, with internal standard correction and duplicate injections to ensure accuracy and reproducibility.

Results are reported in mg per g or per serving. Values are assessed against formulation targets and label claims to confirm dosing, detect degradation, and verify ingredient authenticity.

This test confirms the botanical identity of Sceletium tortuosum (Kanna), including the proprietary Zembrin extract, in raw materials and finished products using High-Performance Thin-Layer Chromatography (HPTLC). The characteristic mesembrine alkaloid fingerprint of the sample is compared against a certified Sceletium tortuosum reference standard to confirm species authenticity and detect substitution with other botanical materials or synthetic alkaloid preparations. Results are reported as confirmed identity or non-conforming.

A representative sample is extracted using methanol or acidified methanol and applied alongside a certified Sceletium tortuosum reference standard onto an HPTLC silica gel plate. The plate is developed in a validated solvent system, examined under UV at 254 nm and 366 nm, and derivatized with Dragendorff or anisaldehyde-sulfuric acid reagent to visualize the characteristic mesembrine alkaloid bands. The resulting fingerprint is compared visually and by densitometric scanning to the reference standard in terms of Rf values, band positions, and color profile.

Sceletium tortuosum is a niche, high-value botanical with a limited number of authenticated suppliers, making identity verification critical for brands sourcing this ingredient. The mesembrine alkaloid profile is species-specific and serves as the key differentiator for HPTLC-based identity confirmation, supporting supplier qualification and cGMP compliance under 21 CFR 111.

This assay measures zinc (Zn) using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). The method provides sensitive and accurate elemental quantification across a wide range of matrices.

Samples are digested and analyzed by ICP-MS under validated conditions. Zinc is ionized in the plasma and detected by mass spectrometry. Calibration with certified reference standards and internal controls ensures accuracy and reproducibility.

Testing verifies label claims, confirms elemental purity, and supports consistent formulation and regulatory compliance.