APIs and Excipients

This is a year of change for the Synthetic Organic Chemical Manufacturers Association (SOCMA), the Washington, DC-based trade association representing chemical batch and custom manufacturers. Following the sale of Informex, its flagship trade show, last fall, the association is advancing key programs, most notably its new ChemStewards program, an environmental, health, safety, and security initiative (EHS&S) that its members began implementing last month.

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

The author suggests that an excipient's functionality can only be determined in the context of a specific formulation and manufacturing process.