Usp 43 nf 38

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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 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.


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


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


USP 43 - NF 37 Monograph of A to Z

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The United States Pharmacopeia (USP) is currently introducing some changes to the format of the USP and to its online platforms. Amongst others USP plans to discontinue printing the USP-NF in the current format.

Changes announced by the USP

The following changes have been announced by the USP.

The USP plans to

  • change the USP-NF Online from a publication-centric into a document-centric model. Therefore, it is planned to post a "Referencing Guideline" to help users with their internal documentation. 
  • still publish the USP-NF standards on a set schedule. However, due to the document-centric platform the official date references are affected:
    - The general publication reference (e.g. USP41-NF36 1S) will no longer be an indication of an official period.
    - Each individual document within the new online publication will have its own official date reference, which is linked to a unique permanent documentary identifier (Unique DocIDs). The Unique DocIDs will only change when there is a revision to a document and do not change with each publication. 
  • remove the publication name from the document view of a documentary standard from the History Tab. The "Switch Version" drop-down menu will also be removed.
  • discontinue printing the USP-NF. The USP 43-NF 38 edition will be the last printed edition available! USP published an updated Compendial Notice that provides a timeline for this change.

Pharmacopeial Forum

  • The Pharmacopeial Forum (PF) has already moved to a new online platform (starting with PF 45(1) in January 2019).
  • The legacy PF Online platform will continue to be available for access to the old issues of PF. 
  • New PF content will only be provided on the new PF Online platform.
  • Submitting comments to recent drafts is only possible via the new platform.

Access to Pharmacopeial Forum (PF) online is free of charge. More information about the recent changes to USP can be found  in Frequently Asked Questions (FAQs) on the USP website.

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USP 43-NF 38 – Last Print Edition

Type of Posting: General Announcement
Posting Date: 04-Oct-2019

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.

USP is making these changes to align with the needs and expectations of our stakeholders and enhance support for regulatory compliance. Frequent updates to online systems ensure access to the most current information. Unlike the printed book and USB flash drive, which cannot be updated, the USP–NF Online platform is updated monthly to reflect the latest compendial content changes, including Accelerated Revisions that are posted monthly. In addition, the recent revision of General Notices emphasizes the goal of achieving a single source of official compendial content.  These changes align with the transition to a fully electronic publishing model for USP publications and will also allow USP to target resources toward ongoing enhancements to the USP–NF Online.

USP is committed to ensuring that you have all the information that you need to transition from the print and/or USB flash drive format to an online subscription. Click here for Frequently Asked Questions (FAQs) related to the transition from print/USP flash drive formats to the online format.

To minimize the impact on your internal documentation processes, USP has also created a Referencing Guideline to help your organization transition from using edition numbers as a citation reference to referencing documentary standards within the new platform. The new USP–NF Online platform introduces a more document-centric model for the version control and presentation of our documentary standards. Click here for more information.

Please send questions to the following email address: [email protected]


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Extended Implementation and Comment Period Extension for USP and FCC Publications

Type of Posting: Publication Announcement 
Posting Date: 27-Mar-2020

USP recognizes that stakeholders are currently facing numerous challenges with maintaining normal operations during, and responding to, the Coronavirus disease (COVID-19) global pandemic.  In light of these circumstances, the USP Council of Experts has adjusted the upcoming official/effective dates for the USP–NF and FCC as follows:

  • United States Pharmacopoeia and National Formulary
    • USP 43–NF 38: Official date has been extended by 6 months from May 1, 2020 to November 1, 2020
    • USP 43–NF 38, First Supplement: Official date has been extended by 3 months from August 1, 2020 to November 1, 2020

Per the USP–NF General Notices and Requirements, Section 3.10 Applicability of Standards, early adoption of revised standards in advance of the official date is allowed by USP, unless specified otherwise at the time of publication. 

  • Food Chemicals Codex
    • FCC, Twelfth Edition: Effective date has been extended from June 1, 2020 to December 1, 2020

In addition, USP is extending the comment deadline for Pharmacopeial Forum (PF) 46(2) [Mar.–Apr.] 2020 from May 31, 2020 to July 31, 2020.

The unfolding Coronavirus disease (COVID-19) outbreak is placing unprecedented burdens on the public heath infrastructure, including the drug supply chain.  The above actions are being taken to support industry and regulators while continuing to promote quality and public health during this difficult time.   

At this time USP does not intend to broadly adjust official dates for accelerated revisions (i.e., Errata, Revision Bulletins, or Interim Revision Announcements for the USP-NF and Errata, Immediate Standards and Expedited Standards for the FCC). USP will also consider additional requests for delayed implementation and comment period extensions on an as-needed basis. 

In addition to proactively adjusting official dates and comment timelines for USP publications, USP may facilitate urgent compendial actions if necessary to prevent supply disruptions and ensure the availability of existing/new treatments. 

Click here to learn more about USP’s comprehensive program to support the public health response to the COVID-19 pandemic.

Should you have any questions, please contact Jessica Simpson, Senior Manager Compendial Operations at [email protected] 



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