Chemical Medicines

Your mission is to deliver pure, high-quality medicines to those who need them. We help you to do that with official Reference Standards. Ensuring the identity, quality, purity, and consistency of medication is fundamental to protecting public health. It is the foundation of everything we do. With USP, you get more than just the standards.

You have resources and support to help you achieve the results you need while meeting the required pharmaceutical quality guidelines. The U.S. government enforces USP’s official standards. Our monographs and reference standards give regulators and drug manufacturers confidence that only high-quality medicines reach consumers.

What are official Reference Standards?
official usp reference standards

Official reference standards are those that are explicitly specified in an official USP compendial monograph for use in US Pharmacopeia-National Formulary (USP–NF) tests and assays. Where use of a USP Reference Standard is indicated, only the official standard can provide a conclusive determination of compliance with compendial specifications. All prescription and over-the-counter medicines that are available in the United States must, by federal law, meet USP–NF public standards, where such standards exist.

Workshops & Courses
Reference Standards development process
comparing pills

Hear our planning and suitability-for-use teams discuss the importance of active and ongoing development of new standards and of testing for reliable performance over the lifetime of the product.

Performance Verification Test (PVT)

The PVT assesses dissolution apparatus performance using the USP reference standard material and procedures. This page includes resources that may be used for the PVT. The PVT is an integral part of USP General Chapter <711> Dissolution.

Impurities for Development

When you need to understand impurities, let trusted USP experts help with our new Impurities for Development service (IfD). We isolate, identify, synthesize and characterize impurities to help ensure you deliver quality medicines. IfD is the only custom impurity development service that is supported by the official USP Reference Standards and the USP–NF.