ANALYTICAL SUPPORT FOR FUNCTIONAL FOODS, NUTRITIONAL PRODUCTS AND FOOD SAFETY.
Research and Development, Product Support, Food Safety,
Method Development and Routine QA/QC Testing
ADPEN is a true independent contract laboratory offering 5 - 7 Day Turnaround for most analyses, at regular prices! We are here to provide you full support for your product development, research and quality assurance / quality control needs.
ADPEN is a world leader in LC/MS, LC/MS/MS, HPLC, GC and GC/MS analysis of functional foods, nutritional products, nutraceuticals and herbals. Supporting analyses include pesticide residue screens, aristolochic acid analysis, LC/MS product fingerprint, heavy metals analysis, microbiological, US Pharmacopeia (USP) and AOAC methodologies, USP disintegration and dissolution tests. Analysis of fruit juices and other food products for adulteration, using FT-IR. Analysis of beverages and juices for HMF to determine improper product handling and storage.
We can ensure the safety and quality of your raw materials and finished products by providing the best analytical service available, worldwide.
ADPEN 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), INA and other official and/or validated methods.
ADPEN is working in method validation programs for the standardization and advancement of nutraceutical testing. We 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. We are conducting collaborative method validation studies with AOAC for ephedra HPLC and LC/MS methods.
METHOD DEVELOPMENT AND VALIDATION
ADPEN is working in method development and validation programs for the standardization and advancement of nutraceutical testing. We have developed and validated an LC/MS method for the analysis of Black Cohosh and its triterpene glycosides. The Black Cohosh method was developed and validated in conjunction with The Institute for Nutraceutical Advancement (INA) as a Primary Validation Lab. Other collaborative work for the INA Method Validation Program included the Ginkgo biloba method by HPLC. These methods are available from INA or from ADPEN for distribution. ADPEN has also participated in collaborative AOAC International, NIH/FDA studies for the validation of Ephedra methods in nutritionals and biological matrices by HPLC and LC/MS/MS. Methods are to be published by AOAC International.
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 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 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 especific 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.
The Food and Drug Administration (FDA) has issued a letter 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 letter indicates 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 guideline. Let ADPEN protect you from possible liabilities and legal action from the presence of aristolochic acid in Chinese herbals. ADPEN is the expert in testing for aristolochic acid.
We test the things that make this world a better place to live!