USP Reference Standards – Recent Developments and Future High Impact Topics

Tina S. Morris, Compendial Science, USP - United States Pharmacopeia, MD, USA (reutl@bioforum.co.il)

The United States Pharmacopeia manages a collection of currently more than 3000 reference materials in support of associated documentary standards. Beyond the traditional compendial uses described in monographs and chapters, USP is increasingly working on the development of additional reference materials that support users in a variety of analytical development areas and span the pharmaceutical development lifecycle. As method performance and validation paradigms evolve to a product lifecycle-centric view and the introduction of new measurement technologies is accelerating, appropriate reference materials that support determinations of equivalence, allow method transitions and establish or confirm method performance criteria, are all the more important, especially in the area of complex materials like complex biologics, non-biologics, and natural products, and even traditional chemical medicines.