Clearing the Air on Residual Solvents

The i's have been dotted, and the t's have been crossed. After years of revisions, debates, and delays, the USP General Chapter 467 Residual Solvents will finally take effect on July 1, 2008. Although most large, multinational pharmaceutical companies have been preparing for these requirements for some time, there is still a significant portion of the industry, especially smaller firms, that are either not aware of how USP ‹467› will change their analytical practices or are in denial that the standards will directly affect them.

Many raw materials used to manufacture pharmaceutical products contain residual solvents at various levels. Because USP ‹467› applies to all compendial drug substances, excipients, and products, this chapter influences all aspects of the industry. Despite the preparation and even after several workshops and conferences on the topic, confusion and questions remain about where the solvent limits actually apply, how the methods should be established, when the data should be reported, and what information is required from ingredient suppliers. To help answer these questions, industry experts and regulators are collectively encouraging analysts to pay attention to the details in the chapter.