USP Extends Time to Meet Residual Solvent Standards

July 24, 2007

The US Pharmacopeia (Rockville, MD, USP, www.usp.org) 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 US Pharmacopeia (Rockville, MD, USP, www.usp.org) 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 revised 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.

Residual solvents are one of three main types of impurities in pharmaceutical products (the other two are organic and inorganic impurities). All products affected by the extension still remain subject to FDA control. The USP residual solvents standards only affect drug products and ingredients with monographs in USP–NF.