The United States Pharmacopeia (USP) is a non–governmental, official public. USP Monographs are standards that specify the quality attributes of. Quality research, quality control and testing in bacteriology, mycology,. The current USP monograph include the following: (1) Definition—No change. (2) Packaging and storage—Storage conditions to protect from light are added. (3) USP Reference standards—A reference standard for Alcohol is added for use in the Identification test. (4) Identification—Tests A and B are replaced with a more defini.
USP–NF Updates. (posted 12–Feb–2020). (posted 03–Feb–2020).
(posted 03–Feb–2020). (posted 31–Jan–2020). (posted 31–Jan–2020). (posted 31–Jan–2020)USP–NF ComponentsUSP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary ( NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.
Excipient monographs are in the NF. MonographsA monograph includes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification.
The specification consists of a series of tests, procedures for the tests, and acceptance criteria. These tests and procedures require the use of official. Medicinal ingredients and products will have the stipulated strength, quality, and purity if they conform to the requirements of the monograph and relevant general chapters.General ChaptersTests and procedures referred to in multiple monographs are described in detail in the USP–NF general chapters. General NoticesThe General Notices provide definitions for terms used in the monographs, as well as information that is necessary to interpret the monograph requirements. Official RecognitionThe U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States.
A drug product in the U.S. Market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding. Standards Established through a Public ProcessUSP creates and continuously revises USP–NF standards through a unique public–private collaborative process, which involves pharmaceutical scientists in industry, academia, and government as well as other interested parties from anywhere in the world.