United State Pharmacopoeia 2018 USP 41-NF 36 

USP 41- NF 36

This section provides background information on the United States Pharmacopeial Convention (USP), as well as general information about the 41st revision of the United States Pharmacopeia (USP 41) and the 36th edition of the National Formulary (NF 36) and their Supplements. Unless otherwise noted, the text in USP 41-NF 3 6 is official May 1, 2018, the text in the First Supplement to USP 41-NF 36 1s official August 1, 2018, and the text in the Second Supplement to USP 41-NF 36 is official December 1, 2018.


USP-NF contains official substance (ingredient) and prod­uct monographs for official articles recognized in USP-NF

(see General Notices 2.20 Official Articles). USP-NF also in­cludes monographs for compounded preparations. With few ex ions, such as articles covered by Global Health monograph  all articles for which monographs are provided in Fare legally marketed in the United States or are contained in legally marketed articles. Global Health mono­graphs are provided for articles that are not approved or regally marketed in the United States, but that have been approved by a stringent regulatory authority [as defined by the World Health Organization (WHO)] ancf are used for es­sential purposes in other parts of the world.

A USP-NF monograph for an official substance, product, or preparation may consist of various components, including the article's name; definition; packaging, storage, and other requirements; and a specification. General chapters provide frequently cited procedures, sometimes with acceptance cri­teria, in order to compile into one location repetitive infor­mation that is applicable to many monographs. See General Notices 3. 10 Appl1cability of Standards for more information about standards contained in USP-NF monographs and gen­eral chapters.

New and revised monographs and general chapters and omitted mono9raphs from this edition are indicated in the Admissions section.

USP-NF Organization-The USP-NF is published online as the USP􀀌NF Online. USP-NF is also printed as a five-volume set. To facilitate convenient use and reference, all five volumes include the combined index, as well as the USP General Notices and the Guide to General Chapters. Volume 1 includes front matter (Mission and Preface, People, govern­ance pages and websites, and Admissions/ Annotations) and USP monographs A-L Volume 2 includes USP monographs

J-Z. Volume 3 includes Global Health monographs, Dietary Supplements monographs, NF Admissions/Annotations, Excipients, and NF monographs. Volume 4 includes general chapters numbered below 1000 (General Tests and Assays-in­cluding chapter charts), Reagents, and Reference Tables. Volume 5 includes general chapters numbered above 1000 (General Information) and Dietary Supplements general chap­ters. General chapters specific to dietary supplements are included in numerical order with the rest of the general chapters in USP. Excipient monographs are usually presented in NF but also may appear in USP with suitable cross-referencing when they are also drug substances. The Excipients section (Volume 3) presents a tabulation of excipi­ents by functional category.

Supplement Supplements to USP-NF follow a standard schedule each year: the First Supplement is published in Feb­ruary and becomes official August 1. The Second Supplement is published in June and becomes official December 1 . Users of USP print products must retain Supplements and check the "Official Text" section of USP's website to have up-to­date official text. The USP-NF Online is updated with each Supplement or annual revision. Each time a new edition or

Supplement is released during the subscription period, a new electronic version is issued. The Index in each Supplement is

cumulative and includes citations to the annuai revision and, for the Second Supplement, citations to the First Supplement.

The contents of the two Supplements are integrated into the annual edition of the following year, along with new official revisions that have been adopted since the Second Supple­ment to the previous compendia.

Revisions to USP-NF-USP-NF is continuously revised by an exceptional process of public involvement and substantial interaction between USP and its stakeholders, both domesti­cally and internationally. Revisions are presented annually in the USP-NF and in twice-yearly Supplements, and as Acceler­ated Revisions on USP's website [Errata, Interim Revision An­nouncements (IRAs), and Revision Bulletins].

Standard Revisions-USP's standard revision process calls for publication of a proposed revision in the Pharmacopeial Forum (PF) for a 90-day notice and comment period and, after the revision is approved by the relevant USP Expert Committee, publication in the next USP-NF or Supplement, as applicable. Learn more about the development and revi­sion process on the USP.

Accelerated Revisions-The Accelerated Revision process is used to make revisions to USP-NF official more quickly than through USP's Standard Revision process. Learn more about Revision Bulletins, Interim Revision Announcements (IRA), Er­rata, and the criteria for and implementation. Modification of Compendia! References-USP and its Expert Committees periodically deem it necessary to modify general chapter titles or similar text that may be referenced in other standards throughout the USP-NF. When this oc­curs, USP staff undertake a rigorous process for identifying and updating such references. These updates may occur through a routine revision, or, in cases in which an update appears to present no significant change in the affected standard, through a direct update of the reference in that standard without providing an opportunity for notice and comment. In all cases, USP will publish on its website a notice indicating the source change, any resulting refer­ences, and whether those references will be updated through a routine revision or a direct update.

Updating Chemical Information-Updates to the Chemical Information section at the beginning of mono­graphs occur on an ongoing basis and are not identified with revision symbols. Chemical names and molecular weights are updated when a monograph undergoes revision to match the official source, United States Adopted Names

(USAN). Chemical structures are updated on a continuous basis.

Chemical names typically reflect the naming conventions at the time of the monograph development or revision. If the nomenclature rules of CAS or IUPAC are significantly changed, the chemical names can be revised or added to implement those rules. Molecular weights are derived from the chemical formula and are based on the table of atomic weights. Atomic weights are recommended by the IUPAC and reflect the isotopic composition of normal terrestrial material. When the IUPAC recommended values are changed, it is understood that the changes in molecular weights will be made in due course.

Graphical representation of the chemical compound struc­tures is intended as a visual aid to help establish chemical identity and is understood to represent one of many possi­ble ways to depict the molecule. Addition of a graphical representation or changes in such representation, that result in the same chemical information, e.g., a flipped chiral mol­ecule or adding a molecule structure, may be introduced outside of the revision process. It is also understood that in the case of tautomerism, the molecule depicted may be one of the tautomers, but it is intended to represent all isomers in equilibrium. Stereogenic centers depicted with plain bonds imply mixtures of pertinent stereomers-enantiomer, diastereomers, epimers (anomers), etc.

Depending on the timing of these updates, users may see a difference in a chemical structure between the publica­tions in PF and USP-NF, and between the USP-NF and the USP-NF Online.

Shading and Symbols-Shading is used to identify text that has been modified, added, or deleted since it was last published. Symbols identify the beginning and end of each revision or nonharmonized text. The following table summa­rizes the types of symbols and the associated subscripts used in USP publications:   Also, in the USP-NF Online, monographs and general chapters that have been revised but not yet published in the USP-NF or its Supplements (e.g., as Accelerated Revisions) will contain icons that will link to the page on the USP website where the new official text can be viewed. These icons will link to Accelerated Revisions (Revision Bulletins, Interim Revision Announcements, and Errata) and Stage 6 Harmonization (see Harmonization Activities below).

Commentary-For revisions that are published for public review and comment in PF, the proposal may advance to official status or be republished in PF for further notice and comment. If comments are received, they are considered and incorporated as appropriate by the Expert Commit­tee(s). In cases where proposals advance to official status without republication in PF, a summary of comments re­ceived and the appropriate Expert Committee's responses are published in the Commentary section of the USP website at the time the revision is published.

The Commentary is not part of the official text and is not intended to be enforceable by regulatory authorities. Rather, it explains the basis of the Expert Committee's response to public comments. If there is a difference between the con­tents of the Commentary and the official text, the official text prevails. In case of a dispute or question of interpreta­tion, the language of the official text, alone and indepen­dent of the Commentary, shall prevail.

Print and Electronic Presentations-See General Notices 2. 10 Official Text for more information about USP-NF product formats.

USP-NF Translations-Translations of the USP-NF are available in Spanish, Russian, and Chinese. The Spanish translation is current; other translations are based on previ­ous revisions of the USP-NF.

USP Reference Standards-The use of USP Reference Standards promotes uniform quality of drugs and supports reliability and consistency by those performing compliance testing and other users of USP-NF, including manufacturers, buyers, and regulatory authorities. USP Reference Standards are referenced in specific procedures in both monographs and general chapters. USP advances this material via careful characterization studies and collaborative testing, followed by review and approval of the compendia! use of the refer­ence material by Expert Committees of the Council of Ex­perts. The USP Catalog, which lists the collection of USP Reference Standards, and more information about use and storage, can be accessed on USP. This program benefits from the widespread voluntary contribution of suitable materials and test data from pharmaceutical manufacturers. USP participates in several collaborative activities with global pharmacopeias in both bilateral and multilateral set­tings. Examples of USP's current activities include the following.

Pharmacopeial Discussion Group-USP harmonizes pharmacopeial excipient monographs and general chapters through the Pharmacopeial Discussion Group (PDG), which includes representatives from the European, Japanese, and United States pharmacopeias, and WHO (as an observer). According to the PDG definition, "a pharmacopeial general chapter or other pharmacopeial document is harmonized when a pharmaceutical substance or product tested by the document's harmonized procedure yields the same results, and the same accept/reject decision is reached." Information regarding PDG, including history, the PDG working proce­dure, a glossary, and lists of monographs and general chap­ters that have completed stages 1-6 of the pharmacopeial  pharmonization process, resulting in an approved USP Stage 6 Harmonization text.

International Meeting of the World Pharmacopeias USP works with WHO and global pharmacopeial partners on the strategy and establishment of Good Pharmacopoeia! Practices (GPhP) as a set of guiding principles for the appro­priate establishment of pharmacopeial standards.

Adopt/ Adapt Agreements-USP grants the rights to copy and/or adapt USP standards for use in other pharma­copeias through this formal mechanism.

Agreements-USP partners with pharmacopeias for the Joint development of pharmacope1al standards using this informal process.

USP Exchange Programs-USP regularly welcomes the exchange of scientific personnel through this program, with the goal of sharing scientific knowledge among global orga­nizations involved in standards setting and the effective use of standards.


Compendium is an electronic compendium that includes all compounding-related general chapters from the USP-NF as well as the supporting general chapters that are referenced in the compounding general chapters and in USP-NF Gen­eral Notices. The purpose of the USP Compounding Compen­dium is to provide compounding practitioners with conven­ient access to associated general chapters.

USP Herbal Medicines Compendium-The USP Herbal Medicines Compendium (HMC) is an online compendium that helps ensure the quality of the herbal ingredients used in herbal medicines. HMC monographs provide quality specifi­cations-tests, procedures, and acceptance criteria-with validated analytical procedures and allied reference materials that aid in conformity assessment. HMC can help ingredient manufacturers, herbal product manufacturers, regulatory agencies, and other stakeholders to assess conformance of herbal medicinal ingredients with independent public stan­dards and to control the quality of articles moving in inter­national commerce. The HMC is available at https://hmc. usp.org.

USP Dietary Supplements Compendium-The Dietary Supplements Compendium combines, in a two-volume set, USP-NF standards for dietary supplements, standards and in­formation from the Food Chemicals Codex, regulatory and industry documents, and other tools and resources. It is published every two years as a hardcover edition.

Food Chemicals Codex-The Food Chemicals Codex (FCC) is a compendium of internationally recognized monograph standards and tests for the purity and quality of food ingre­dients, e.g., preservatives, flavorings, colorings, and nutri­ents. FCC is published every two years, with supplements every six months, and is available in print and electronic formats. Proposed revisions to FCC are available for public viewing and comment through the FCC Forum. The FCC Forum can be accessed free of charge at forum.foodchemi­calscodex.org.


Chromatographic Columns-This comprehensive refer­ence, previously titled Chromatographic Reagents, provides detailed information needed to conduct chromatographic procedures found in USP-NF. Chromatographic Columns lists the brand names of the column reagents cited in every pro­posal for new or revised gas- or liquid-chromatographic ana­lytical procedures that have been published in PF since 1980. Chromatographic Columns also helps to track which column reagents were used to validate analytical procedures that have become official. The branded column reagents list is updated bimonthly and maintained on USP's website.

USP Dictionary-The USP Dictionary of USAN and International Drug Names provides, in a single volume, the most up-to-date United States Adopted Names of drugs; official USP-NF names; nonproprietary, brand, and chemical names; graphic formulas; molecular formulas and weights; CAS reg­istry numbers and code designations; drug manufacturers; and pharrnacologic and therapeutic categories. The Diction­ary helps to ensure the accuracy of the following: product labeling; reports, articles, and correspondence; FDA regula­tory filings; and pharmaceutical package inserts. 

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