Thomas E. Chapman, Ph.D., director of pharmaceutical sciences for BioScreen Testing Services, Inc., has been appointed as chair of the USP Residual Solvents Project Team. Dr. Chapman will also be teaching a USP seminar, Navigating Chapter 467 Residual Solvents, in San Francisco and Fullerton, CA.

USP and PDA held a joint conference last month in Bethesda, MD to discuss suitable test methods and debated requirements. Dr. Chapman was co-chair of the conference, along with John K. Towns, Ph.D., from PDA. Residual Solvents 467 will be replacing Organic Volatile Impurities 467 to harmonize the requirements with the current ICH guidelines and the EP method. The official change will take place in July of this year, delayed from January.

The delay in implementation is due to industry response to the original notice and test method, first released in November 2005. The chapter appeared as a requirement in each USP and NF monograph. Until the chapter is finalized, Organic Volatile Impurities 467 requirements should be met, as stated in each monograph. All current requirements are listed in the USP General Notice, found on the organization’s website, www.usp.org.

“General notice is a very important part of the USP,” Dr. Chapman stated, “but a lot of people overlook it.” The upcoming USP seminar is designed to help people understand the changes to the chapter, and to aid in determining what the requirement will be for their product, be it an excipient, API or finished product. The three-hour seminar is offered in cities across the U.S.