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Residual Solvents – New FDA Draft Guidance

The USP established a new test requirement for control of residual solvents in finished dosage forms. The new test is in the General Chapter <467> “Residual Solvents”  [Sorry no link – password protected].  The test became official July 1, 2008.  In turn, on August 5, 2008 the FDA issued a draft guidance stating that all NDA and ANDA current and pending applications for products marketed with a USP monograph must comply with this new test.

Thus, if an NDA (usually only a 505(b)(2) RLD would have an existing USP monograph)  or ANDA has been approved, the applicant must submit a new finished product specification in the annual report.  If the application is pending, then an amendment must be made immediately.

Please note that you may not actually need to test the finished drug product.  If you control the API and excipients for residual solvents and you don’t use solvents in the preparation of your drug product, then the test is not needed.  You do, however, need to document this decision and submit to FDA the rationale.

Furthermore, you need not use the USP test methods.  You may use a properly validated test method.