News

Posted On: 07/09/2007

USP Gives Manufacturers More Time to Meet Residual Solvent Standards

PharmaManufacturing.com

The U.S. Pharmacopeia recently announced that the implementation period for its USP-NF General Notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter <467> has been extended from July 1, 2007 to July 1, 2008.

The USP-NF requirements are designed to ensure consistency from one manufacturer to another in several areas: testing for residual solvents, procedures for the test, acceptance criteria and, when needed, reference materials.

"Manufacturers support USP's approach and have worked to understand and, where possible, conform to it,” said Roger L. Williams, M.D., executive vice president and CEO of USP. "However, USP recognizes that the revised approach has created substantial demands on pharmaceutical manufacturers, because it affects thousands of ingredients and drug products. The one-year extension will give manufacturers additional time to develop the needed analytical capability or obtain the residual solvents information needed from their suppliers to conform to the new standards.”

Residual solvents are one of three main types of impurities in pharmaceutical products (the other two are organic and inorganic impurities). USP has no evidence to indicate that any existing product in the U.S. market poses any special risk for residual solvents. All products affected by the extension still remain subject to FDA control. USP residual solvents only affect drug products and ingredients with monographs in USP-NF.

For more information, please send an email to mediarelations@usp.org.