![]() They also describe the tests to validate that a medicine and its ingredients meet these criteria. ![]() Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance.USP-NF includes three types of quality standards for prescription medicines: In addition, USP is utilized in over 140 countries worldwide and integrated into the laws of more than 40 countries. USP is an official quality standard for medicines marketed in the US. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients. It is the most comprehensive source for medicine quality standards in the world. The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic active pharmaceutical ingredients (APIs) and excipients (inactive ingredients). ![]()
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