USP Reference Standards - Eurolab SA

USP Reference Standards What is a Reference Standard (RS)? Why are Reference Standards important? How does USP develop a RS? How are RSs used? How should I store andhandle my USP RS? RS FAQsUSP Reference Standards Topics Highly characterized specimens of: drug substances excipients impurities degradation products biologics food ingredients dietary supplements compendial reagents performance test tablets Rigorously tested by USP, industry, and government scientists Intended for use in compendial methods (a few exceptions) Established and released under the authority of the USP Board of Trustees and Council of ExpertsWhat is a USP Reference Standard? Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation, August 2000 Reference Standards Types of Standards A Reference standard ( primary standard) may be obtained from the USP-NF or other official sources ( CBER, 21 CFR ).

Data Evaluation and Internal Review Analyze Data/Value Assignment –Mass balance approach 100% - % sum of all impurities (w/w) –Impurities including

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