USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
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Heavy Metals• Significant impact to industry expected• Current methodology is outdated– Difficult to run, not specific– Safety issues– Almost impossible to fail due to poor recovery issues• Stimuli article, Pharmacopeial Forum 34(5):1345-1347[Sept-Oct 2008] <strong>and</strong> on the <strong>USP</strong> web site• Revised will be a performance-basedapproach– Chapter will provide acceptance criteria <strong>and</strong> st<strong>and</strong>ards– Any method that meets the criteria is acceptable– Chapter provides default procedure
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