The FDA has recently published "Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States" (August 2008). The FDA guidance mirrors the ICH guideline for residual solvents (document Q3C (R3)). The FDA guidance states that testing should conform to the latest edition of USP <467> and is applicable to all NDA and ANDA filings for compendial drug products. The updated USP general chapter <467> "Residual Solvents" became effective on July 1, 2008 and replaces the previous <467> "Organic Volatile Impurities" general chapter. The <467> testing can present a challenge for pharmaceutical manufacturers, because of the many caveats associated with the chapter. Microbac- STRL can provide both the technical guidance and analytical support for meeting chapter <467> requirements.
or call Booth No. 225