This general information chapter is derived from the Certificate of Analysis Guide for Bulk Pharmaceutical Excipients, prepared by the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) and is meant to serve as a guide for the preparation and appropriate use of a Certificate of Analysis (COA) for pharmaceutical excipients. The goals are to standardize the content and suggest a format for COAs for excipients, and to clearly define the roles and responsibilities for the excipient manufacturer and distributor. The detailed definitions and discussions are intended to establish a uniform approach. By providing this foundation for mutual understanding, the COA will serve as an important element of the overall supply chain controls needed to provide the user with assurance of excipient conformance to specification and its suitability for use in pharmaceuticals.