USP Gives Manufacturers More Time to Meet Residual Solvent Standards

Rockville, MD (June 15)-The United States Pharmacopeia (USP) announced that its implementation period for the USP–National Formulary (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 the following areas: testing for residual solvents, procedures for the test, acceptance criteria and, as applicable, reference materials. Residual solvents are one of three main types of impurities in pharmaceutical products, along with organic and inorganic impurities.

“Manufacturers support USP’s approach and have worked to understand and, where possible, conform to it,” said Roger L. Williams, MD, executive vice-president and CEO of USP, in a USP media release. “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.”

According to the release, USP has no evidence that any product currently in the US market poses a special risk for residual solvents. All products affected by the extension still remain subject to approval by the

US Food and Drug Administration

(Rockville, MD). USP residual solvents requirements only affect drug products and ingredients with monographs in

USP-NF

.