03.02.15
The ABC-AHP-NCNPR Botanical Adulterants Program has published a Laboratory Guidance Document (LGD) series for botanical ingredients. The LGD on skullcap (Scutellaria lateriflora) is the first in the program’s new series of comprehensive, extensively peer-reviewed, and up-to-date analytical assessments of methods for authentication of the identity of ingredients and detection of adulterants. These free documents—available at no cost thanks to the program’s underwriters and supporters—are intended for use by quality control personnel and lab technicians in the herbal medicine, botanical ingredient and dietary supplement sectors to help them choose the most appropriate techniques and methods for their specific analytical needs.
The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program (BAP) is an international consortium of non-profit organizations, analytical laboratories, industry members, professional scientists and others that advise industry, researchers, health professionals and the public about the various challenges related to adulterated herb and botanical ingredients sold in commerce.
The ABC-AHP-NCNPR Laboratory Guidance Documents are intended to provide reliable expert guidance on suitable methods to comply with the mandated requirements of testing for identity, purity, strength and composition outlined in current Good Manufacturing Practices (cGMPs) for dietary supplements. Per the cGMPs, it is the responsibility of dietary supplement manufacturers to “conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.”
The program’s LGDs provide information about the most suitable analytical methods for detection of certain adulterants and authentication of specific botanical materials in the form of whole, cut or powdered raw materials, extracts and essential oils. Recommendations are based on a thorough review of available analytical methods (e.g., from official and unofficial compendia as well as peer-reviewed literature) and input from up to 20 peer reviewers from academia, government and industry in multiple countries. The primary assessment of each method is based on its performance characteristics (i.e., suitability in detecting known adulterants); labor and analysis time comprise the secondary evaluation criteria.
The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program (BAP) is an international consortium of non-profit organizations, analytical laboratories, industry members, professional scientists and others that advise industry, researchers, health professionals and the public about the various challenges related to adulterated herb and botanical ingredients sold in commerce.
The ABC-AHP-NCNPR Laboratory Guidance Documents are intended to provide reliable expert guidance on suitable methods to comply with the mandated requirements of testing for identity, purity, strength and composition outlined in current Good Manufacturing Practices (cGMPs) for dietary supplements. Per the cGMPs, it is the responsibility of dietary supplement manufacturers to “conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.”
The program’s LGDs provide information about the most suitable analytical methods for detection of certain adulterants and authentication of specific botanical materials in the form of whole, cut or powdered raw materials, extracts and essential oils. Recommendations are based on a thorough review of available analytical methods (e.g., from official and unofficial compendia as well as peer-reviewed literature) and input from up to 20 peer reviewers from academia, government and industry in multiple countries. The primary assessment of each method is based on its performance characteristics (i.e., suitability in detecting known adulterants); labor and analysis time comprise the secondary evaluation criteria.