Residual Solvents: Alternate Validated Methods
October 30, 2009 By: Nathan T. Whitford
The USP General Chapter <467> on Residual Solvents became effective on July 1, 2008. Alternate methods may need to be developed and validated for compounds and any other unlisted solvents used in manufacturing that cannot be tested by the General Chapter's GC method. Lancaster Laboratories' analysts have been utilizing a technique referred to as a self-validating method. The benefit to this self-validating method approach includes a faster timeline and is more cost effective than the traditional approach for clients having a short term or infrequent need for testing. |