United States Pharmacopeia

The United States Pharmacopeia is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.

In critical medical applications seals must be made from an even cleaner list of ingredients than those allowed by the FDA. The USP Class VI outlines requirements for system toxicity and intracutaneous toxicity for these even cleaner compounds.

USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tight requirements for leachates.

USP's standards are recognized and used in more than 130 countries. These standards have been helping to ensure good pharmaceutical care for people throughout the world for more than 185 years.

Safe and effective USP is an independent, science-based public health organization. As a self-sustaining non-profit organization, USP is funded through revenues from the sale of products and services that help to ensure good pharmaceutical care.

What is the USP-NF?

The United States Pharmacopeia-National Formulary (USP-NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

Official recognition

USP Reference Standards are based directly on official monographs in the USP-NF, whose standards and procedures are enforceable by the U.S. Food and Drug Administration (FDA).

Observant scientistsTherefore, USP Reference Standards are recognized as the official standards in the U.S., and their use makes it easier to comply with statutory requirements.

USP's Reference Standards are widely recognized and trusted in more than 130 countries around the world.

USP Class VI was especially developed for the pharmaceutical industry.

These guidelines help in selecting the correct elastomer for use in high purity sanitary hygienic seals where critical pure water, process fluids and SIP (Steam in Place) or CIP (Clean in Place) environments exist.

USP Class VI stipulates that cytotoxicity tests are carried out.