USP Reference Standards

USP is an independent, scientific nonprofit organization that is focused on building trust in the supply of safe, quality medicines. USP owns the trademark and also it owns the copyright of the pharmacopeia by itself. It’s a more than 200 years old organization.

USP establishes written (documentary) and physical (reference) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that the products developed are of the appropriate identity, strength, quality, purity, and consistency

USP presently provides more than 4000 Reference Standards which are highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. USP Reference Standards are also specified for use in conducting official USP–NF tests and assays.

USP’s reference standards for food ingredients can also be found in its Food Chemicals Codex as well as authentic substance & high-quality chemical samples which are of great help in analytical, clinical, pharmaceutical and research laboratories.

USP Publications

The USP is published in a combined volume with the National Formulary as the USP-NF. The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It consists of standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.

USP–NF monographs and methods can help to ensure compliance with required U.S. quality standards, work to world-recognized standards of precision and accuracy, validate test results against proven benchmarks, establish and validate in-house standard operating procedures, and specifications and expedite new product development and approvals.

The USP- NF contains more than 4,900 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. It has step -by -step guidance for assays, tests & procedures for more than 350 general chapters making it easy for you to find the required information.

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