What are USP general notices?
Notices) presents the basic assumptions, definitions, and default. The title specified in a monograph is the official title for such. conditions for the interpretation and application of the United States. article. Other names considered to be synonyms of the official titles.
What are USP requirements?
Developing documentary standards and Reference Standards is the core of what we do at USP. These standards help to assess the quality, strength, identity, and purity of chemical medicines, biologics, food chemicals and ingredients, dietary supplements, among other items.
Which USP chapters are mandatory?
The text says that a General Chapter with a number below <1000> is mandatory, whereas General Chapters with numbers above <1000> are considered interpretations and thus do not represent official standards and binding requirements.
What is USP General Notices in pharmacy?
The General Notices and Requirements (hereinafter referred to as the General Notices) and general requirements appearing in General Chapters provide in summary form the basic guidelines for the interpretation and application of the standards, tests, assays, and other specifications of the United States Pharmacopeia and …
How many chapters are there in USP?
More than 40 General Chapters and 170 compounding monographs. Available in PDF format.
What are the major sections and their uses in any USP-NF monograph?
USP-NF includes three types of quality standards for prescription medicines: Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.
How many USP standards are there?
3,500 Reference Standards
USP currently offers more than 3,500 Reference Standards—highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators.
How many general chapters does USP have?
How many volumes are there in USP?
Volumes USP is printed in three volumes.
What is the general notices and requirements section?
The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia ( USP ) and the National Formulary ( NF ).
What happens if an article does not comply with the USP?
Where an article fails to comply in identity with the identity prescribed in the USP, or contains an added substance that interferes with the prescribed assays and tests, such article shall be designated by a name that is clearly distinguishing and differentiating from any name recognized in the Pharmacopeia.
What is an article recognized in USP or NF?
An article recognized in USP or NF shall comply with thecompendial standards if the article is a medical device, component intended for a medical device, dietary supple-ment, dietary ingredient, or other ingredient that is in- tended for incorporation into a dietary supplement, and islabeled as conforming to the USP or NF.
What is the USP’s policy on dietary supplements?
If a dietary supplement purports to be or is represented as an official product and such claim is determined by the USP not to be made in good faith, it is the policy of the USP to seek appropriate legal redress. Products Not Marketed in the United States— Interest in the USP outside the United States has always existed.