Residual Solvents in ANDAs: Questions and Answers

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Dr. Analytical
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Residual Solvents in ANDAs: Questions and Answers

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After the revised USP General Chapter <467> Residual Solvents became official as of July 1, 2008, attempts at implementation of this USP chapter have resulted in confusion among ANDA stakeholders. On October 10, 2008, FDA met with IPEC Americas, IPEC Europe, GPhA, CHPA, PhRMA, and SOCMA BPTF1 to discuss implementation of USP <467>. In addition, FDA received comments from GPhA, PhRMA, APIC2, and others requesting additional clarification regarding the implementation of USP <467> for generic drugs. The FDA Office of Generic Drugs (OGD) has carefully considered these comments and suggestions and is providing the following clarifying questions and answers. The clarifications include a flexible, stepwise approach to application of USP
<467> to ANDAs to ensure availability of low cost, high quality, safe, and effective generic drugs that meet USP <467> requirements.

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i'm late,the link has expired

i'm late,the link has expired?i can't find it?