United State Pharmacopoeia 2020 USP 43- NF 38   

United State Pharmacopoeia 2020 USP 43- NF 38



USP 43–NF 38

The USP 43–NF 38 is the last edition that will be available in print or on a USB flash drive. Future supplements and editions – including the First and Second Supplements to USP 43–NF 38 – will not be printed or on flash drives. Starting with the First Supplement to USP 43–NF 38 that will be published on February 1, 2020, print and USB flash drive formats will not be available. Only the online format will contain all current USP–NF content.

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).

Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise.  Where the require-ments of an individual monograph differ from the General Notices or a general chapter, the monograph requirements apply and super-sede the requirements of the General Notices or the general chapter, whether or not the monograph explicitly states the difference.


Official text is text contained in USP and NF, including monographs, general chapters, and these General Notices. Revi-sions to official text are provided in Supplements, Interim Revision Announcements, and Revision Bulletins. General chapters numbered from 1000 to 1999 are considered interpretive and are intended to provide information on, give definition to, or describe a particular subject. They contain no mandatory requirements applicable to any official article unless specifically referenced in these General No-tices, a monograph, or a general chapter numbered below 1000.

General chapters numbered above 2000 apply only to articles that are intended for use as dietary ingredients and dietary supplements.

Official Articles

An official article is an article that is recognized in USP or NF. An article is deemed to be recognized and included in a compendium when a monograph for the article is published in the compen-dium and an official date is generally or specifically assigned to the monograph.

The title specified in a monograph is the official title for such article. Other names considered to be synonyms of the official titles may not be used as substitutes for official titles.

Official articles include both official substances and official products. An official substance is a drug substance, excipient, diet-ary ingredient, other ingredient, or component of a finished device for which the monograph title includes no indication of the nature of the finished form.

An official product is a drug product, dietary supplement, com-pounded preparation, or finished device for which a monograph is provided.


MONOGRAPHS AND GENERAL CHAPTERS

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 crite-ria that help ensure the identity, strength, quality, and purity of the article. For general requirements relating to specific monog 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 in-terchangeability in such instances, users may wish to ascertain func-tional equivalence or determine such characteristics before use.


4.20. General Chapters

Each general chapter is assigned a number that appears in angbrackets adjacent to the chapter name (e.g. Chromatography) 

General chapters may contain the following:

Descriptions of tests and procedures for application through in-dividual 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, dispensin and packaging practices, or

General guidance to manufacturers of official substances or of-ficial 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.


MONOGRAPH COMPONENTS

5.10. Molecular Formula

The use of the molecular formula for the active ingredient(s)

named in defining the required strength of a compendial article is intended to designate the chemical entity or entities, as given in the complete chemical name of the article, having absolute (100 per-cent) purity.

5.20. Added Substances, Excipients, and Ingredients

Substances are regarded as unsuitable for inclusion in an official article and therefore prohibited unless: (1) they do not exceed the minimum quantity required for providing their intended effect; (2) their presence does not impair the bioavailability, therapeutic efficacy, or safety of the official article; and (3) they do not interfere with the assays and tests prescribed for determining compliance with the compendial standards. The air in a container of an official article may, where appropr ate, be evacuated or be replaced by carbon dioxide, helium, argon, or nitrogen, or by a mixture of these gases. The use of such gas need not be declared in the labeling.

Guidelines for Packaging and Storage Statements USP–NF Monographs

In order to provide users of the USP and NF with proper gui-dance on how to package and store official articles, every mono-

graph in the USP and NF shall have a packaging and storage

specification.

For the packaging portion of the statement, the choice of containers is given in this section 10, Preservation, Packaging, Storage, and Labeling, and includes Light-Resistant Container, Well-Closed Container, Tight Container, Hermetic Container, Single-Unit Container, Single-Dose Container, Unit-Dose Container, and Unit-of-Use Container. For most preparations, the choice is determined by the container in which it shall be dispensed (e.g., tight, well-

closed, hermetic, unit-of-use, etc.). For drug substances, the choice would appear to be tight, well-closed, or, where needed, a light-

resistant container. For excipients, given their typical nature as

large-volume commodity items, with containers ranging from drums to tank cars, a well-closed container is an appropriate default. Therefore, in the absence of data indicating a need for a more protective class of container, the phrase “Preserve in well-closed containers” should be used as a default for excipients.

Levofloxacin Monograph in USP 43 

   

Dextrose Excipient Monograph in USP 43- NF 38

    





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