The objective for the USP Workshop on DNA Standards for Botanical Identification is to provide a forum for discussion on the recent developments in the DNA technologies for botanical identification and to discuss the stakeholder needs to implement the DNA methods as a routine QA tool. The expected outcomes from the workshop are (a) to understand the regulatory approaches and experiences from the industry in starting to implement the new methodologies for botanical identification, (b) to gain an understanding of the strengths and limitations of the new technologies to produce suitable identification methods and ways to compare results, (c) to identify the potential solutions to the challenges associated with voucher specimens and public databases, and (d) to identify stakeholder needs for validated DNA methods and the potential role for USP in providing testing methods and reference standards for the identification of botanical articles.
This course offers an overview of the botanical identification methodologies codified in the USP General Chapters <563> Identification of Articles of Botanical Origin, <202> Identification of Fixed Oils by Thin Layer Chromatography and <203> HPTLC Procedure for Identification of Articles of Botanical Origin, and in USP monographs for botanical articles. The content of these chapters and their application to botanical identification will be discussed, and the USP philosophy of comprehensive evaluation of the botanical article quality, stemming from orthogonality of different identification methodologies, will be presented. Importance of macroscopic and microscopic assessments will be highlighted. Numerous USP monograph examples and case studies in which incomplete compendial evaluation could invite adulteration will be examined.
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