This section provides background information on the United States Pharmacopeial Convention (USP), as well as general information about the 42nd revision of the United States Pharmacopeia (USP 42) and the 37th edition of the National Formulary (NF 37) and their Supplements. Unless otherwise noted, the text in USP 42-NF 37 is official May 1, 2019, the text in the First Supplemen to USP 42-NF 37 is official August 1, 2019, and the text in the Second Supplement to USP 42-NF 37 is official December 1, 2019.
MISSION STATEMENT.USP-NF is published in continuing pursuit of the mission of USP: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.
HISTORY.USP has a rich history, dating back to 1820, when 11 physicians met in the Senate Chamber of the U.S. Capitol building to establish a pharmacopeia for the United States. Learn more about USP's history and major milestones on the USP website (https://www.usp.org/about/usp-timeline).
CONTENT OF U5P-NF.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 exceptions, such as articles covered by Clobal Health monographs, all articles for which monographs are provided in USP-NF are legally marketed in the United States or are contained in legally marketed articles. Clobal Health monographs are provided for articles that are not approved or legally marketed in the United States, but that have been approved by a stringent regulatory authority [as defined by the World Health Organization (WHO)] and 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 Applicability of Standards for more information about standards contained in USP-NF monographs and general chapters.
New and revised monographs and general chapters and omitted monographs 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-I. 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. Supplements—Supplements to USP-NF follow a standard schedule each year: the First Supplement is published in February and becomes official August 1 unless otherwise noted. The Second Supplement is published in June and becomes official December 1 unless otherwise noted. Users of USP print products must retain Supplements and check the "Official Text" section of USP's website to have up-to-date official text. The USP-NF Online is updated with each annual revision, Supplement, and Accelerated Revision. The Index in each Supplement is cumulative and includes citations to the annual 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-NF Online [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.
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 of each on the USP website (http://www.uspnf.com/official-text).
Modification of Compendial 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 tautomkerism, 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:
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 compendial 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's website (http://www.usp.org/reference-standards). This program benefits from the widespread voluntary contribution of suitable materials and test data from pharmaceutical manufacturers.

VOLUME 1

Mission Statement and Preface v

People 2015-2020 Revision Cycle ix

      Officers ix

      Board of Trustees ix

      Council of Experts ix

      Expert Committees x

      In Memoriam xvii

Members and Delegates of the United States Pharmacopeial Convention, as of May 31, 2018 xviii

2017 Recognition of Monograph and Reference Material Donors xxv

Articles of Incorporation xxvii

USP Governance xxviii

      Bylaws xxviii

      Rules and Procedures xxviii

      USP Policies xxviii

Admissions xxix

Articles Admitted to USP 42 by Supplement xxix

      New Articles Appearing in USP 42 That Were Not Included in USP 41 Including Supplements xxix

      Articles Included in USP 41 But Not Included in USP 42 xxix

Annotated List xxxi

General Notices and Requirements 3

Guide to General Chapters 13

USP42

USP 42, A-I Monographs 21

Index I-1

VOLUME 2

General Notices and Requirements 2433

Guide to General Chapters 2443

USP 42, J-Z Monographs 2449

Index I-1

VOLUME 3

General Notices and Requirements 4683

Guide to General Chapters 4693

Global Health Monographs 4699

Dietary Supplements Monographs 4701

NF 37

Admissions 5537

      Articles Admitted to NF 37 by Supplement 5537

      New Articles Appearing in NF 37 That Were Not and NF Articles Included in NF 36 Including Supplements 5537

      New Articles Appearing in NF 37 5537

Annotated List 5538

USP and NF Excipients 5539

NF 37 Monographs 5551

Index I-1

VOLUME 4

General Notices and Requirements 6047

Guide to General Chapters 6059

Reagents, Indicators, and Solutions 6065

      Reagent Specifications 6070

      Indicators and Indicator Test Papers 6158

      Buffer Solutions 6161

      Colorimetric Solutions 6163

      Test Solutions 6164

      Volumetric Solutions 6176

      Chromatographic Columns 6191

Reference Tables 6197

      Containers for Dispensing Capsules and Tablets 6197

      Description and Relative Solubility of USP and NF Articles 6210

      Approximate Solubilities of USP and NF Articles 6272

      Atomic Weights 6282

      Half-Lives of Selected Radionuclides 6283

      Alcoholometric Table 6284

      Intrinsic Viscosity Table 6287

General Chapters See page 6059 for detailed contents

      General Tests and Assays 6339

      General Requirements for Tests and Assays 6339

      Apparatus for Tests and Assays 6378

      Microbiological Tests 6382

      Biological Tests and Assays 6414

      Chemical Tests and Assays 6513

      Physical Tests and Determinations 6746

Index I-1

VOLUME 5

General Notices and Requirements 7105

Guide to General Chapters 7117

      General Information Chapters 7123

      Dietary Supplement Chapters 8509

Index I-1

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