United State Pharmacopoeia 2018 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.
OTHER USP COMPENDIA
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.
OTHER USP RESOURCES
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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