NSF 363 :2016

The purpose of NSF/IPEC/ANSI 363 is to serve as an evaluation tool for analyzing pharmaceutical excipients. Certification to this Standard serves as a communication tool between manufacturers of excipients and finished product, pharmaceutical regulators, pharmacy organizations, and consumers. This Standard provides guidance to allow for the determination that a pharmaceutical excipient is within the specifications stated by the manufacturer, either qualitatively or quantitatively, and that it does not contain specific undeclared contaminants. In some instances, validated laboratory methods are not yet available for analyzing certain ingredients.