USP – National Formulary

Description

The United States Pharmacopeia (USP) is a compendium of drug, supplement and food ingredients standards issued by the nonprofit United States Pharmacopeia Convention and has been recognized by the United States government. However, USP is not an institution or organization of government. Established in 1906 independently, USP has a mission to improve global health through public standards and related programs to help ensure the quality, safety, and benefits of food and medicine.

Considering that USP is a collection of summaries devoted to qualitative and quantitative research in pharmacy and food, USP can also be found in form of various pharmacopeia or international standard scientific reference books which are also the output of the USP Convention and have their own specifications. The three compendia are the USP Reference Standard (USP RS), USP-National Formulary (USP-NF), and USP Food Chemicals Codex (USP FCC).

USP – National Formulary

USP – National Formulary is a monograph. It is a combination of USP and National Formulary (NF). The USP-NF monograph focuses on things like drug substances, drug dosages, to compounded preparations which can also be found in USP. In the USP-NF, it is also more focused on excipients given that the USP-NF itself plays a very important role as a reference for the Federal Food, Drug, and Cosmetic Act under the Public Health Service Act.

The composition of the USP-NF consists of three chapters:

  • Monographs, which include the identification and specifications of medicines or ingredients (composition) in full
  • General Chapters, which includes a complete description of various tests and procedures required for testing as stated previously in the monograph
  • General Notices, which includes an explanation of the terms used in monographs, as well as essential things that need to be known in interpreting monographs

Besides that, the USP-NF monograph also mainly includes specific matters consisting of a variety or series of tests, various procedures for particular tests, and acceptance criteria. Moreover, the USP-NF monograph is also equipped with various information about the name of the substance or composition of the drug substance, its definition, packaging, storage, to labeling requirements. All pharmaceutical products (medicines), whatever they are, if it meets USP-NF requirements, it is already confirmed that the level of quality, purity, and strength are guaranteed in accordance with the health standards.

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