Reference Standards Development Process

When USP identifies the need for a new Reference Standard (based on monographs in the USP–NF that require its use), it requests bulk materials from pharmaceutical manufacturers. USP subjects the candidate materials it receives from manufacturers to rigorous analysis and review. USP tests the materials in its own laboratories then requests collaborative testing by FDA and independent laboratories. USP compares and analyzes the results of this collaborative testing and prepares a report for its voluntary Reference Standards Committee. The committee determines whether the candidate material is suitable to be established as an official USP Reference Standard. USP's meticulous packaging, stringent quality control checks, and Continued Suitability for Use testing enhance the quality and integrity of its official Reference Standards.