USP Extends Time to Meet Residual Solvent Standards
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.
Thermo Fisher Opens Advanced Therapies Collaboration Center in California
April 18th 2025The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.
