NUTRITIONAL & NUTRACEUTICAL TESTING

vegetables-nutraADPEN is a world leader in LC/MS, LC/MS/MS, HPLC, GC and GC/MS analysis of nutraceuticals, herbals, functional foods, beverages, nutritional products and raw materials. Our supporting analyses include pesticide residue screens, aristolochic acid analysis, LC/MS product fingerprint, heavy metals analysis, microbiological, US Pharmacopea (USP) and AOAC methodologies, and USP disintegration and dissolution tests. We also provide analysis of fruit juices and other food products for adulteration, using FT-IR as well as analysis of sports enhancement products for quality control and adulteration and test for product adulteration with Viagra and other drugs.

ADPEN provides fingerprint analysis using certified herbs for comparison with your raw material and extracts. Fingerprint is performed by LC/MS, a state-of-the-art analytical tool.

ADPEN can perform LC/MS and GC/MS tests to determine possible raw material or product contamination. The events that occurred on September 11th and after have brought chemical and bio-terrorism to the forefront of food safety concerns. These tests will provide raw material suppliers, contract manufacturers, and food, beverage and nutritional manufacturers with the means to test for specific contaminants.

We can ensure the safety and quality of your raw materials and finished products by providing the best nutritional and nutraceutical testing services available, worldwide.

METHODS

Chemist with ErlenmeyerADPEN uses quality standards and validated methods for all analyses.  ADPEN uses USP guidelines (ICH), or AOAC or other guidelines if required by client, for the validation of methods.  We use our own validated methods, AOAC, USP, Food Chemical Codex (FCC), Institute for Nutraceutical Advancement (INA) and other official and/or validated methods.

ADPEN has been working in method validation programs for the standardization and advancement of nutraceutical testing.  We have completed collaborative Method Validation Programs for the Institute for Nutraceutical Advancement (INA) for Ginkgo biloba by HPLC and as a Primary Validation Lab, we have completed method development/method validation of an LC/MS method for the analysis of Black Cohosh.  The Black Cohosh LC/MS method has been submitted to USP for review and approval for inclusion in USP as official method.

METHOD DEVELOPMENT AND VALIDATION

ADPEN uses AOAC, USP, Food Chemical Codex  (FCC), INA and other official methods.  ADPEN also develops and validates methods for our own use.  These methods are state-of-the-art and of world class quality.  ADPEN published methods are available for review to our clients, newly developed methods are proprietary and can be licensed to our clients.  ADPEN can develop and validate methods for new finished products and raw materials.  ADPEN participates and conducts collaborative method validation work with the AOAC.  Currently we are conducting collaborative validation studies for HPLC and LC/MS ephedra methods.

PRODUCT DEVELOPMENT

ADPEN can provide product development support and support for existing products.  Safeguard your products by using good science, make sure that your label claims are backed up by proper scientific testing.  Inaccurate claims can lead to FDA fines over $1 million and possible targeting by consumer oriented studies.  Do not accept analyses by spectrophotometry to support quantitation of raw material or final product specifications.  Require specific analyses by HPLC, LC/MS, GC or GC/MS which are industry standard.  Quantitation by spectrophotometry leads to misleading higher results, which can create problems if your products are tested using proper analytical tools.  ADPEN can help you make accurate label claims by properly testing your raw materials and final products.

FDA CONCERNS

Cargo ShipThe Food and Drug Administration (FDA) has issued letters to the industry to communicate their concern about aristolochic acid in dietary supplements and other products that may be marketed as traditional herbal medicines.  The letters indicate steps that manufacturers and distributors should consider in light of the recent life-threatening adverse incidents.  A comprehensive list of plants known to contain aristolochic acid and plants which may become adulterated with Aristolochia spp. is included with the FDA letter.  FDA indicates that the manufacturer bears the primary responsibility for ensuring that its dietary supplement products are safe.   Traditional Chinese herbal medicines should be tested to make sure that they do not contain or are free of any contamination with aristolochic acid .  See FDA Letter to the Industry

ADPEN Laboratories has improved the FDA method for determination of aristolochic acid by LC/MS/MS in various matrices.  The ADPEN method uses LC/MS/MS to determine aristolochic acid at a limit of quantitation (LOQ) of 100 ppb, five times lower than the FDA method.  The procedure as required by FDA uses LC/MS technology to confirm or deny the presence of aristolochic acid.  LC/MS is required to be able to detect at the low levels required by the FDA.  Testing only with HPLC does not satisfy the FDA requirements and will not be sufficient to release your shipment from Customs quarantine.  Be aware of the FDA guidelines.  Let ADPEN protect you from possible liabilities and legal action from the presence of aristolochic acid in your Chinese herbal products.  A Certificate of Analysis is provided with results of aristolochic acid analyses and provided to the FDA for product release from quarantine when requested.  Raw data, chromatograms and LC/MS spectra are also provided upon request.  ADPEN is the expert in testing for aristolochic acid in Chinese herbals.

Instrumentation

We have a wide range of instrumentation at our disposal.

Trackbacks