4.10. Monographs
Monographs set forth the article's name, definition, specification, and other requirements related to packaging, storage, and labeling. The specification consists of tests, procedures, and acceptance criteria that help ensure the identity, strength, quality, and purity of the article. For general requirements relating to specific monograph sections, see section 5, Monograph Components.
Because monographs may not provide standards for all relevant characteristics, some official substances may conform to the USP or NF standard but differ with regard to nonstandardized properties that are relevant to their use in specific preparations. To assure interchangeability in such instances, users may wish to ascertain functional equivalence or determine such characteristics before use.
4.10.10. Applicability of Test Procedures
A single monograph may include several different tests, procedures, and/or acceptance criteria that reflect attributes of different manufacturers' articles. Such alternatives may be presented for different polymorphic forms, impurities, hydrates, and dissolution cases. Monographs indicate the tests, procedures, and/or acceptance criteria to be used and the required labeling.
4.10.20. Acceptance Criteria
The acceptance criteria allow for analytical error, for unavoidable variations in manufacturing and compounding, and for deterioration to an extent considered acceptable under practical conditions. The existence of compendial acceptance criteria does not constitute a basis for a claim that an official substance that more nearly approaches 100 percent purity “exceeds” compendial quality. Similarly, the fact that an article has been prepared to tighter criteria than those specified in the monograph does not constitute a basis for a claim that the article “exceeds” the compendial requirements.
An official product shall be formulated with the intent to provide 100 percent of the quantity of each ingredient declared on the label. Where the minimum amount of a substance present in a dietary supplement is required by law to be higher than the lower acceptance criterion allowed for in the monograph, the upper acceptance criterion contained in the monograph may be increased by a corresponding amount.
The acceptance criteria specified in individual monographs and in the general chapters for compounded preparations are based on such attributes of quality as might be expected to characterize an article compounded from suitable bulk drug substances and ingredients, using the procedures provided or recognized principles of good compounding practice, as described in these compendia.
4.20. General Chapters
Each general chapter is assigned a number that appears in angle brackets adjacent to the chapter name (e.g., Chromatography 621). General chapters may contain the following:
  • Descriptions of tests and procedures for application through individual monographs,
  • Descriptions and specifications of conditions and practices for pharmaceutical compounding,
  • General information for the interpretation of the compendial requirements,
  • Descriptions of general pharmaceutical storage, dispensing, and packaging practices, or
  • General guidance to manufacturers of official substances or official products.
When a general chapter is referenced in a monograph, acceptance criteria may be presented after a colon.
Some chapters may serve as introductory overviews of a test or of analytical techniques. They may reference other general chapters that contain techniques, details of the procedures, and, at times, acceptance criteria.