GUID - 8 en-US

Printed on: Wed Apr 27 2022, 07:05:23 AM(EST) Official Status: Currently Official on 27-Apr-2022 DocId: 1_GUID-6E790F63-0496-4C20-AF21-E7C283E3343E_8_en-US
Printed by: rabah meziani Official Date: Official as of 01-May-2021 Document Type: FRONT MATTER @2022 USPC
DOI Ref: 7yg1e DOI: https://doi.org/10.31003/USPNF_M99989_08_01
1
GENERAL NOTICES AND

REQUIREMENTS
Applying to Standards, Tests, Assays, and Other
Specifications of the United States Pharmacopeia
al
2.10. Official Text......................................................... 3 6.50. Preparation of Solutions..................................... 10
2.20. Official Articles..................................................... 4 6.50.10. Filtration............................................ 10
2.30. Legal Recognition................................................ 4 6.50.20. Solutions........................................... 10
3.10. Applicability of Standards.................................... 4 6.60. Units Necessary to Complete a Test................... 10
3.10.10. Applicability of Standards to Drug
Products, Drug Substances, and
ci
Excipients................................................. 5
6.60.10. Tablets...............................................
6.60.20. Capsules............................................
6.70. Reagents...........................................................
10
10
10
3.10.20. Applicability of Standards to Medical 6.80. Equipment......................................................... 10
Devices, Dietary Supplements, and Their 6.80.10. Apparatus for Measurement............... 10
ffi
Components and Ingredients................... 5 6.80.20. Instrumental Apparatus...................... 10
3.10.30. Applicability of Standards to the Practice 6.80.30. Temperature Reading Devices............ 11
of Compounding..................................... 5 7.10. Interpretation of Requirements.......................... 11
3.10.40. Applicability of Global Health 7.10.5. Nominal Concentrations in Equations.. 11
Monographs............................................ 5 7.10.10. Equivalence Statements in Titrimetric
3.20. Indicating Conformance...................................... 5 Procedures............................................. 11
O
4.10. Monographs........................................................ 6 7.20. Rounding Rules................................................. 11

4.10.10. Applicability of Test Procedures........... 6 8.10. Abbreviations.................................................... 11
4.10.20. Acceptance Criteria.............................. 6 8.20. About................................................................ 11
4.20. General Chapters................................................. 6 8.30. Alcohol Content................................................ 11
5.10. Molecular Formula............................................... 7 8.40. Atomic Weights................................................. 12
5.20. Added Substances............................................... 7 8.50. Blank Determinations........................................ 12
5.20.10. Added Substances in Official 8.60. Concomitantly................................................... 12
Substances............................................... 7 8.70. Desiccator......................................................... 12
5.20.20. Added Substances (Excipients and 8.80. Logarithms........................................................ 12
Ingredients) in Official Products............... 7 8.90. Microbial Strain................................................. 12
5.30. Description and Solubility.................................... 7 8.100. Negligible........................................................ 12
5.40. Identification....................................................... 8 8.110. NLT/NMT........................................................ 12
5.50. Assay................................................................... 8 8.120. Odor............................................................... 12
5.50.10. Units of Potency (Biological)................ 8 8.130. Percent............................................................ 12
5.60. Impurities and Foreign Substances....................... 8 8.140. Percentage Concentrations.............................. 12
5.60.10. Other Impurities in USP and NF 8.150. Pressure........................................................... 13
Articles..................................................... 8 8.160. Reaction Time.................................................. 13
5.60.20. Residual Solvents in USP and NF 8.170. Specific Gravity................................................ 13
Articles..................................................... 8 8.180. Temperatures.................................................. 13
5.60.30. Elemental Impurities in USP Drug Products 8.190. Time................................................................ 13
and Dietary Supplements......................... 8 8.200. Transfer........................................................... 13
5.70. Performance Tests............................................... 9 8.210. Vacuum........................................................... 13
5.80. USP Reference Standards..................................... 9 8.220. Vacuum Desiccator.......................................... 13
6.10. Safe Laboratory Practices..................................... 9
6.20. Automated Procedures........................................ 9
6.30. Alternative and Harmonized Methods and
Procedures.......................................................... 9
6.40. Dried, Anhydrous, Ignited, or Solvent-Free Basis.. 9
6.40.10. Ignite to Constant Weight................... 9
6.40.20. Dried to Constant Weight.................. 10
https://online.uspnf.com/uspnf/document/1_GUID-6E790F63-0496-4C20-AF21-E7C283E3343E_8_en-US 1/15
2
8.230. Water.............................................................. 13
8.230.10. Water as an Ingredient in an Official
Product.................................................. 13
8.230.20. Water in the Manufacture of Official
Substances............................................. 13
8.230.30. Water in a Compendial Procedure... 13
8.240. Weights and Measures..................................... 13
9.10. Use of Metric Units............................................ 14
9.20. Changes in Volume........................................... 15
10.10. Packaging and Storage.................................... 15
10.20. Labeling.......................................................... 15
al
ci
ffi
O
3
GENERAL NOTICES AND

REQUIREMENTS
Requirements stated in these General Notices apply to all
The General Notices and Requirements section (the General articles recognized in the USP and NF (the “compendia”) and
Notices) presents the basic assumptions, definitions, and to all general chapters unless specifically stated otherwise.
default conditions for the interpretation and application of the
United States Pharmacopeia (USP) and the National Formulary
Change to read:
(NF).
al
1. TITLE AND REVISION ci
The full title of this joint compendium is The Pharmacopeia USP–NF 2021 Issue 1: Published November 1, 2020
of the United States of America and the National Formulary USP–NF 2021 Issue 2: Published February 1, 2021
▲ (USP 1-May-2021) (USP–NF ▲ (USP 1-May-2021)). Although USP and
▲ ▲
USP–NF 2021 Issue 3: Published June 1, 2021
ffi
NF are published together and share these General Notices, “Issues” represent dates on which new and revised content
they are separate compendia. ▲▲ (USP 1-May-2021) Where the terms is added to the USP–NF. The USP–NF is in continuous revision,
“USP”, “NF”, or “USP–NF” are used without further with standards having official dates that correspond to their
qualification, they refer to the currently official standard. specific revision histories.▲ (USP 1-May-2021)
▲
New and revised content is added to the USP–NF
periodically (see section 2.10 Official Text). Routine revisions
O
are published three times a year, on the following dates, Change to read:
corresponding with three “issues”:
2. OFFICIAL STATUS AND

LEGAL RECOGNITION
2.10. Official Text supersede previously published content and become official
Official text of the USP and NF is published on the date indicated.
▲
online at▲ (USP 1-May-2021) ▲https:// Interim Revision Announcements are Accelerated Revisions to
online.uspnf.com▲ (ERR 1-May-2021). USP and NF that contain revisions and their official dates.
Routine revisions are published in the USP–NF Revision Bulletins are Accelerated Revisions to official text or
postponements that require expedited publication. They
▲ (USP 1-May-2021) and become official on the date indicated,
▲
usually six months after publication. generally are official immediately unless otherwise specified
Accelerated Revisions, published periodically in the USP–NF, in the Revision Bulletin.
Errata are Accelerated Revisions representing corrections to
▲ (USP 1-May-2021)are designed to make revisions official more
▲
items erroneously published.
quickly than through the routine process for publishing
Periodically, a non-official volume of associated revisions
standards in the USP–NF. ▲▲ (USP 1-May-2021)Accelerated Revisions
and additions to the USP–NF is published in print ▲or other
may also be published on the Official Text section of USP’s
media.▲ (USP 1-May-2021) This volume is intended to serve as a
website (www.uspnf.com/official-text). Accelerated Revisions
4
historical reference document and is not considered official authorities may enforce the standards presented in the USP
text. and NF, but because recognition of the USP and NF may vary
by country, users should understand applicable laws and
2.20. Official Articles regulations. In the United States under the Federal Food, Drug,
and Cosmetic Act (FDCA), both USP and NF are recognized as
An official article is an article that is recognized in USP or NF. official compendia. A drug with a name recognized in USP–NF
An article is deemed to be recognized and included in a must comply with compendial identity standards or be
compendium when a monograph for the article is published deemed adulterated, misbranded, or both. See, e.g., FDCA §
in the compendium and an official date is generally or 501(b) and 502(e)(3)(b); also U.S. Food and Drug
specifically assigned to the monograph. Administration (FDA) regulations, 21 CFR § 299.5(a&b). To
The title specified in a monograph is the official title for such avoid being deemed adulterated, such drugs must also
article. Other names considered to be synonyms of the official comply with compendial standards for strength, quality, and
titles may not be used as substitutes for official titles. For drug purity, unless labeled to show all respects in which the drug
products that incorporate a sensor to detect that the product differs. See, e.g., FDCA § 501(b) and 21 CFR § 299.5(c). In
has been administered, the official title shall be the title addition, to avoid being deemed misbranded, drugs
specified in the relevant drug product monograph plus the recognized in USP–NF must also be packaged and labeled in
words “with sensor”. compliance with compendial standards. See FDCA § 502(g).
Official articles include both official substances and official A dietary supplement represented as conforming to
products. An official substance is a drug substance, excipient, specifications in USP will be deemed a misbranded food if it
dietary ingredient, other ingredient, or component of a fails to so conform. See FDCA § 403(s)(2)(D).
finished device for which the monograph title includes no Enforcement of USP standards is the responsibility of FDA
indication of the nature of the finished form. and other government authorities in the U.S. and elsewhere.
An official product is a drug product, dietary supplement, USP has no role in enforcement.
al
compounded preparation, or finished device for which a
monograph is provided.
Change to read:
2.30. Legal Recognition
The USP and NF are recognized in the laws and regulations
of many countries throughout the world. Regulatory
ci
3. CONFORMANCE TO
ffi
STANDARDS
O
3.10. Applicability of Standards monograph will include such specifications in the text that
Standards for an article recognized in the compendia (USP– states requirements.▲ (USP 1-May-2021)
NF) are expressed in the article’s monograph, applicable “Applicable general chapters” means general chapters
general chapters, and General Notices. The identity, strength, numbered below 1000 or above 2000 that are made
quality, and purity of an article are determined by the official applicable to an article through reference in General Notices, a
tests, procedures, and acceptance criteria, and other monograph, or another applicable general chapter numbered
requirements incorporated in the monograph, in applicable below 1000. Where the requirements of a monograph differ
general chapters, or in the General Notices. from the requirements specified in these General Notices or an
▲
In a monograph, requirements for official articles are applicable general chapter, the monograph requirements
indicated in two ways: (1) for certain monographs, after the apply and supersede the requirements of the General Notices
official title, the primarily informational portions of the text or applicable general chapters, whether or not the monograph
appear first, followed by the text comprising requirements, the explicitly states the difference.
latter section of the monograph being introduced by a double General chapters numbered 1000 to 1999 are for
arrow symbol »; and (2) for monographs more recently informational purposes only. They contain no mandatory
redesigned, requirements appear in the official title and in any tests, assays, or other requirements applicable to any official
text beginning with the section titled “Definition”. In either article, regardless of citation in a general chapter numbered
format, information that appears: (1) after the title but before below 1000, a monograph, or these General Notices. General
the double arrow symbol; (2) after the title but before the chapters numbered above 2000 apply only to articles that are
section titled “Definition”; or (3) in or after the section titled intended for use as dietary ingredients and dietary
“Auxiliary Information” is provided for informational supplements. General chapter citations in NF monographs
purposes. See Preface for information related to updates to refer to USP general chapters.
Chemical Information. Early adoption of revised standards in advance of the official
Where conformance to any specifications represented by date is allowed by USP unless specified otherwise at the time
Chemical Information is critical to establishing identity, purity, of publication. Where revised standards for an existing article
potency, or another quality attribute of an official article, the have been published as final approved “official text” (as
approved in section 2.10 Official Text) but have not yet
5
reached the official date (6 months after publication, unless 3.10.20. Applicability of Standards to Medical Devices,
otherwise specified; see “official date”, section 2.20 Official Dietary Supplements, and Their Components and
Articles), compliance with the revised standard shall not Ingredients
preclude a finding or indication of conformance with An article recognized in USP or NF shall comply with the
compendial standards, unless USP specifies otherwise by compendial standards if the article is a medical device,
prohibiting early adoption in a particular standard. component intended for a medical device, dietary
The standards in the relevant monograph, general supplement, dietary ingredient, or other ingredient that is
chapter(s), and General Notices apply at all times in the life of intended for incorporation into a dietary supplement, and is
the article from production to expiration. It is also noted that labeled as conforming to the USP or NF.
the manufacturer’s specifications, and manufacturing Generally, dietary supplements are prepared from
practices (e.g., Quality by Design, Process Analytical ingredients that meet USP, NF, or Food Chemicals Codex
Technology, and Real Time Release Testing initiatives), standards. Where such standards do not exist, substances may
generally are followed to ensure that the article will comply be used in dietary supplements if they have been shown to be
with compendial standards until its expiration date, when of acceptable food grade quality using other suitable
stored as directed. Every compendial article in commerce shall procedures.
be so constituted that when examined in accordance with 3.10.30. Applicability of Standards to the Practice of
these assays and test procedures, it meets all applicable Compounding
pharmacopeial requirements (General Notices, monographs, USP compounding practice standards, Pharmaceutical
and general chapters). Thus, any official article is expected to Compounding—Nonsterile Preparations á795ñ and
meet the compendial standards if tested, and any official Pharmaceutical Compounding—Sterile Preparations á797ñ, as
article actually tested as directed in the relevant monograph appropriate, apply to compounding practice or activity
must meet such standards to demonstrate compliance. regardless of whether a monograph exists for the
Some tests, such as those for Dissolution and Uniformity of compounded preparation or these chapters are referenced in
al
Dosage Units, require multiple dosage units in conjunction such a monograph. In the United States, á795ñ and á797ñ are
with a decision scheme. These tests, albeit using a number of not applicable to drugs compounded by entities registered
dosage units, are in fact one determination. These procedures with FDA as outsourcing facilities as defined by FDCA § 503B,
should not be confused with statistical sampling plans. The because such facilities are required to comply with FDA’s
similarity to statistical procedures may seem to suggest an current good manufacturing practice requirements.
intent to make inference to some larger group of units, but in
all cases, statements about whether the compendial standard
is met apply only to the units tested. Repeats, replicates,
ci Compounded preparations, including drug products
compounded by outsourcing facilities, may also be subject to
applicable monographs; see section 2.20 Official Articles and
statistical rejection of outliers, or extrapolations of results to section 4.10 Monographs.
larger populations, as well as the necessity and appropriate ▲
3.10.40. Applicability of Global Health Monographs
ffi
frequency of batch testing, are neither specified nor Global Health Monographs (GHM) do not apply to
proscribed by the compendia; such decisions are based on the products marketed in the United States. Monographs in this
objectives of the testing. Frequency of testing and sampling section of the USP–NF are not considered “applicable” USP–NF
are left to the preferences or direction of those performing monographs for use in pharmacy compounding in the United
compliance testing, and other users of USP–NF, including States under the Federal Food, Drug, and Cosmetic Act. GHMs
manufacturers, buyers, or regulatory authorities. are provided for possible use outside of the United States, at
O
Official products are prepared according to recognized the discretion of individual government authorities.
principles of good manufacturing practice and from Applicability of a GHM, in whole or in part, along with the
ingredients that meet USP or NF standards, where standards applicability of associated General Notices and general chapter
for such ingredients exist (for dietary supplements, see section requirements, in whole or in part, is at the discretion of
3.10.20 Applicability of Standards to Medical Devices, Dietary individual government authorities.
Supplements, and Their Components and Ingredients). Where a product purports to comply with the requirements
Official substances are prepared according to recognized of an official GHM, it is recommended that the product label
principles of good manufacturing practice and from or labeling clearly specify conformance to a GHM, e.g.,
ingredients complying with specifications designed to ensure “USP-GHM” or “USP–GH”. The designations, “USP–NF”,
that the resultant substances meet the requirements of the “USP”, and “NF” should be used only to indicate conformance
compendial monographs. to USP or NF monographs outside of GHMs (see section 3.20
3.10.10. Applicability of Standards to Drug Products, Indicating Conformance).
Drug Substances, and Excipients The designation “USP–GHM” or “USP–GH” on the label
The applicable USP or NF standard applies to any article may not and does not constitute an endorsement by USP and
marketed in the United States that (1) is recognized in the does not represent assurance by USP that the article is known
compendium and (2) is intended or labeled for use as a drug to comply with the relevant standards. USP may seek legal
or as an ingredient in a drug. Such articles (drug products, redress if an article purports to be or is represented as an official
drug substances, and excipients) include both human drugs GHM article and such claim is determined by USP not to be
(whether dispensed by prescription, “over the counter”, or made in good faith.
otherwise), as well as animal drugs. The applicable standard Enforcement of GHM requirements is the responsibility of
applies to such articles whether or not the added designation government authorities outside of the U.S. USP has no role in
“USP” or “NF” is used. The standards apply equally to articles enforcement.▲ (USP 1-May-2021)
bearing the official titles or names derived by transposition of
the definitive words of official titles or transposition in the 3.20. Indicating Conformance
order of the names of two or more drug substances in official
titles, or where there is use of synonyms with the intent or A drug product, drug substance, or excipient may use the
effect of suggesting a significant degree of identity with the designation “USP” or “NF” in conjunction with its official title
official title or name. or elsewhere on the label only when (1) a monograph is
provided in the specified compendium and (2) the article
complies with the identity prescribed in the specified
compendium.
6
When a drug product, drug substance, compounded with the relevant standards. USP may seek legal redress if an
preparation, or excipient differs from the relevant USP or NF article purports to be or is represented as an official article in
standard of strength, quality, or purity, as determined by the one of USP’s compendia and such claim is determined by USP
application of the tests, procedures, and acceptance criteria not to be made in good faith.
set forth in the relevant compendium, its difference shall be The designation “USP–NF” may be used on the label of an
plainly stated on its label. article provided that the label also bears a statement such as
When a drug product, drug substance, compounded “Meets NF standards as published by USP”, indicating the
preparation, or excipient fails to comply with the identity particular compendium to which the article purports to apply.
prescribed in USP or NF or contains an added substance that When the letters “USP”, “NF”, or “USP–NF” are used on the
interferes with the prescribed tests and procedures, the article label of an article to indicate compliance with compendial
shall be designated by a name that is clearly distinguishing and standards, the letters shall appear in conjunction with the
differentiating from any name recognized in USP or NF. official title of the article. The letters are not to be enclosed in
A medical device, dietary supplement, or ingredient or any symbol such as a circle, square, etc., and shall appear in
component of a medical device or dietary supplement may use capital letters.
the designation “USP” or “NF” in conjunction with its official If a dietary supplement does not comply with all applicable
title or elsewhere on the label only when (1) a monograph is compendial requirements but contains one or more dietary
provided in the specified compendium and (2) the article ingredients or other ingredients that are recognized in USP or
complies with the monograph standards and other applicable NF, the individual ingredient(s) may be designated as
standards in that compendium. complying with USP or NF standards or being of USP or NF
The designation “USP” or “NF” on the label may not and quality provided that the designation is limited to the
does not constitute an endorsement by USP and does not individual ingredient(s) and does not suggest that the dietary
represent assurance by USP that the article is known to comply supplement complies with USP standards.
al
4. MONOGRAPHS AND ci
GENERAL CHAPTERS
ffi
4.10. Monographs 4.10.20. Acceptance Criteria
Monographs set forth the article’s name, definition, The acceptance criteria allow for analytical error, for
unavoidable variations in manufacturing and compounding,
O
specification, and other requirements related to packaging,

storage, and labeling. The specification consists of tests, and for deterioration to an extent considered acceptable
procedures, and acceptance criteria that help ensure the under practical conditions. The existence of compendial
identity, strength, quality, and purity of the article. For general acceptance criteria does not constitute a basis for a claim that
requirements relating to specific monograph sections, see an official substance that more nearly approaches 100% purity
section 5. Monograph Components. “exceeds” compendial quality. Similarly, the fact that an
Because monographs may not provide standards for all article has been prepared to tighter criteria than those
relevant characteristics, some official substances may conform specified in the monograph does not constitute a basis for a
to the USP or NF standard but differ with regard to claim that the article “exceeds” the compendial requirements.
nonstandardized properties that are relevant to their use in An official product shall be formulated with the intent to
specific preparations. To assure substitutability in such provide 100% of the quantity of each ingredient declared on
instances, users may wish to ascertain functional equivalence the label. Where the minimum amount of a substance present
or determine such characteristics before use. in a dietary supplement is required by law to be higher than
4.10.10. Applicability of Test Procedures the lower acceptance criterion allowed for in the monograph,
A single monograph may include more than one test, the upper acceptance criterion contained in the monograph
procedure, and/or acceptance criterion for the same attribute. may be increased by a corresponding amount.
Unless otherwise specified in the monograph, all tests are The acceptance criteria specified in individual monographs
requirements. In some cases, monograph instructions allow and in the general chapters for compounded preparations are
the selection of tests that reflect attributes of different based on such attributes of quality as might be expected to
manufacturers’ articles, such as different polymorphic forms, characterize an article compounded from suitable bulk drug
impurities, hydrates, and dissolution. Monograph instructions substances and ingredients, using the procedures provided or
indicate the tests, procedures, and/or acceptance criteria to be recognized principles of good compounding practice, as
used and the required labeling. described in these compendia.
The order in which the tests are listed in the monograph is
based on the order in which they are approved by the relevant 4.20. General Chapters
Expert Committee for inclusion in the monograph. Test 1 is Each general chapter is assigned a number that appears in
not necessarily the test for the innovator or for the reference angle brackets adjacent to the chapter name (e.g.,
product. Depending on monograph instructions, a labeling Chromatography á621ñ). General chapters may contain the
statement is not typically required if Test 1 is used. following:
7
• Descriptions of tests and procedures for application • General guidance to manufacturers of official substances
through individual monographs, or official products.
• Descriptions and specifications of conditions and When a general chapter is referenced in a monograph,
practices for pharmaceutical compounding, acceptance criteria may be presented after a colon.
• General information for the interpretation of the Some chapters may serve as introductory overviews of a test
compendial requirements, or of analytical techniques. They may reference other general
• Descriptions of general pharmaceutical storage, chapters that contain techniques, details of the procedures,
dispensing, and packaging practices, or and, at times, acceptance criteria.
5. MONOGRAPH
COMPONENTS
al
5.10. Molecular Formula climatic conditions, provided that the concentrations of drug
The use of the molecular formula for the official substances are not varied and provided that the bioavailability,
substance(s) named in defining the required strength of a therapeutic efficacy, and safety of the preparation are not
compendial article is intended to designate the chemical entity impaired.
or entities, as given in the complete chemical name of the 5.20.20.1. In Compounded Preparations
article, having absolute (100%) purity.
5.20. Added Substances

ci Compounded preparations for which a complete
composition is given shall contain only the ingredients
named in the formulas unless specifically exempted herein
or in the individual monograph. Deviation from the
Added substances are presumed to be unsuitable for specified processes or methods of compounding, although
ffi
inclusion in an official article and therefore prohibited, if their not from the ingredients or proportions thereof, may occur
presence impairs the bioavailability, therapeutic efficacy, or provided that the finished preparation conforms to the
safety of the official article; or they interfere with the assays relevant standards and to preparations produced by
and tests prescribed for determining compliance with the following the specified process.
compendial standards (see section 3.20 Indicating Where a monograph for a compounded preparation calls
Conformance). for an ingredient in an amount expressed on the dried basis,
O
The air in a container of an official article may, where the ingredient need not be dried before use if due allowance
appropriate, be evacuated or be replaced by carbon dioxide, is made for the water or other volatile substances present in
helium, argon, or nitrogen, or by a mixture of these gases. The the quantity taken.
use of such gas need not be declared in the labeling. Specially denatured alcohol formulas are available for use
5.20.10. Added Substances in Official Substances in accordance with federal statutes and regulations of the
Official substances may contain only the specific added Internal Revenue Service. A suitable formula of specially
substances that are permitted by the individual monograph. denatured alcohol may be substituted for Alcohol in the
Such added substances shall not exceed the quantity required manufacture of official preparations intended for internal or
for providing their intended effect. Where such addition is topical use, provided that the denaturant is volatile and does
permitted, the label shall indicate the name(s) and amount(s) not remain in the finished product. A preparation that is
of any added substance(s). intended for topical application to the skin may contain
5.20.20. Added Substances (Excipients and Ingredients) specially denatured alcohol, provided that the denaturant is
in Official Products either a usual ingredient in the preparation or a permissible
Suitable substances and excipients such as antimicrobial added substance; in either case the denaturant shall be
agents, pharmaceutical bases, carriers, coatings, flavors, identified on the label of the topical preparation. Where a
preservatives, stabilizers, and vehicles may be added to an process is given in the individual monograph, any
official product to enhance its stability, usefulness, or elegance, preparation compounded using denatured alcohol shall be
or to facilitate its preparation, unless otherwise specified in the identical to that prepared by the monograph process.
individual monograph. 5.20.20.2. In Dietary Supplements
Added substances and excipients employed solely to impart Additional ingredients may be added to dietary
color may be incorporated into official products other than supplement products provided that the additional
those intended for parenteral or ophthalmic use, in ingredients (1) comply with applicable regulatory
accordance with the regulations pertaining to the use of colors requirements, and (2) do not interfere with the assays and
issued by the FDA, provided such added substances or tests prescribed for determining compliance with
excipients are otherwise appropriate in all respects. (See also compendial standards.
Injections and Implanted Drugs Products á1ñ, Product Quality
Tests Common to Parenteral Dosage Forms, Specific Tests, 5.30. Description and Solubility
Vehicles and added substances, Added substances.)
The proportions of the substances constituting the base in Only where a quantitative solubility test is given in a
ointment and suppository products and preparations may be monograph and is designated as such is it a test for purity.
varied to maintain a suitable consistency under different
8
A monograph may include information regarding the not use the full phrase “USP [product name] Units” that
article’s description. Information about an article’s appears in many USP monograph labeling sections. The term
“description and solubility” also is provided in the reference “USP Units” can be used on product labeling consistent with
table Description and Relative Solubility of USP and NF Articles. USP compendial requirements, provided it is clear from the
The reference table merely denotes the properties of articles context that the potency is stated in terms of USP [product
that comply with monograph standards. The reference table name] Units. In such circumstances it should be clear that
is intended primarily for those who use, prepare, and dispense “USP Units” and “USP [product name] Units” share the same
drugs and/or related articles. Although the information meaning.
provided in monographs and the information in the reference
table may indirectly assist in the preliminary evaluation of an 5.60. Impurities and Foreign Substances
article, it is not intended to serve as a standard or test for
purity. Tests for the presence of impurities and foreign substances
The approximate solubility of a compendial substance is are provided to limit such substances to amounts that are
indicated by one of the following descriptive terms: unobjectionable under conditions in which the article is
customarily employed (see also Impurities in Drug Substances
and Drug Products á1086ñ).
Parts of Solvent Required Nonmonograph tests and acceptance criteria suitable for
Descriptive Term for 1 Part of Solute
detecting and controlling impurities that may result from a
Very soluble Less than 1 change in the processing methods or that may be introduced
from external sources should be employed in addition to the
Freely soluble From 1 to 10
tests provided in the individual monograph, where the
Soluble From 10 to 30 presence of the impurity is inconsistent with applicable good
manufacturing practices or good pharmaceutical practices.
al
Sparingly soluble From 30 to 100
5.60.10. Other Impurities in USP and NF Articles
Slightly soluble From 100 to 1,000 If a USP or NF monograph includes an assay or organic
Very slightly soluble From 1,000 to 10,000
impurity test based on chromatography, other than a test for
residual solvents, and that monograph procedure does not
Greater than or equal to ci detect an impurity present in the substance, the amount and
Practically insoluble, or Insoluble 10,000 identity of the impurity, where both are known, shall be stated
in the labeling (certificate of analysis) of the official substance,
5.40. Identification under the heading Other Impurity(ies).
The presence of any unlabeled other impurity in an official
A compendial test titled Identification is provided as an aid substance is a variance from the standard if the content is 0.1%
in verifying the identity of articles as they are purported to be, or greater. The sum of all Other Impurities combined with the
ffi
e.g., those taken from labeled containers, and to establish monograph-detected impurities may not exceed 2.0% (see
whether it is the article named in USP–NF. The Identification Ordinary Impurities á466ñ), unless otherwise stated in the
test for a particular article may consist of one or more monograph.
procedures. When a compendial Identification test is The following categories of drug substances are excluded
undertaken, all requirements of all specified procedures in the from Other Impurities requirements:
test must be met to satisfy the requirements of the test. Failure
O
of an article to meet all the requirements of a prescribed • Fermentation products and semi-synthetics derived
Identification test (i.e., failure to meet the requirements of all therefrom,
of the specified procedures that are components of that test) • Radiopharmaceuticals,
indicates that the article is mislabeled and/or adulterated. • Biologics,
• Biotechnology-derived products,
5.50. Assay • Peptides,
Assay tests for compounded preparations are not intended • Herbals, and
for evaluating a compounded preparation before dispensing, • Crude products of animal or plant origin.
but instead are intended to serve as the official test in the event Any substance known to be toxic shall not be listed under
of a question or dispute regarding the preparation’s Other Impurities.
conformance to official standards. 5.60.20. Residual Solvents in USP and NF Articles
5.50.10. Units of Potency (Biological) All USP and NF articles are subject to relevant control of
For substances that cannot be completely characterized by residual solvents, even when no test is specified in the
chemical or physical means or that need confirmation of individual monograph. If solvents are used during production,
functionality or tertiary structure, it may be necessary to they must be of suitable quality. In addition, the toxicity and
express quantities of biological activity in units of biological residual level of each solvent shall be taken into consideration,
potency, each defined by an authoritative, designated and the solvents limited according to the principles defined
reference standard. In cases where international reference and the requirements specified in Residual Solvents á467ñ,
materials have been discontinued, international units of using the general methods presented therein or other suitable
potency may be defined in terms of molecular mass, such as methods.
in the cases of vitamins A, D, and E. 5.60.30. Elemental Impurities in USP Drug Products and
Where available, World Health Organization (WHO) Dietary Supplements
international biological standards define the International Elemental impurities in official drug products are controlled
Units (IU). USP monographs refer to the units assigned by USP according to the principles defined and requirements
Reference Standards either directly as International Units (IU) specified in Elemental Impurities—Limits á232ñ. Elemental
or as “USP Units”. For some biological products, units of contaminants in official dietary supplements are controlled
potency are value assigned against a corresponding U.S. according to the principles defined and requirements
Standard established by FDA, whether or not International specified in Elemental Contaminants in Dietary Supplements
Units or USP Units have been defined (see Biologics á1041ñ). á2232ñ.
Note that product-related labeling, e.g., on containers, need
9
5.70. Performance Tests as a material standard of reference, a substance meeting all of

Where content uniformity determinations have been made the compendial monograph requirements for that article shall
using the same analytical methodology specified in the Assay, be used. If any new USP or NF standard requires the use of a
with appropriate allowances made for differences in sample new USP Reference Standard that is not yet available, that
preparation, the average of all of the individual content portion of the standard containing the requirement shall not
uniformity determinations may be used as the Assay value. be official until the specified USP reference material is available.
Announcements of the availability of new USP Reference
Standards and announcements of tests or procedures that are
5.80. USP Reference Standards held in abeyance pending availability of required USP
USP Reference Standards are authentic specimens that have Reference Standards are also available on the “Official Text”
been approved as suitable for use in USP or NF tests and assays tab of USP’s website (www.uspnf.com). Unless otherwise
(see USP Reference Standards á11ñ). Where USP or NF tests or directed in the procedure in the individual monograph or in a
assays call for the use of a USP Reference Standard, only those general chapter, USP Reference Standards are to be used in
results obtained using the specified USP Reference Standard accordance with the instructions on the label of the Reference
are conclusive. Where a procedure calls for the use of a Standard.
compendial article rather than for a USP Reference Standard
6. TESTING PRACTICES AND
al
PROCEDURES ci
6.10. Safe Laboratory Practices Certain general chapters contain a statement that the text
In performing compendial procedures, safe laboratory in question is harmonized with the corresponding text of the
practices shall be followed, including precautionary measures, European Pharmacopoeia and/or the Japanese Pharmacopoeia
ffi
protective equipment, and work practices consistent with the and that these texts are interchangeable. Therefore, if a
chemicals and procedures used. Before undertaking any substance or preparation is found to comply with a
procedure described in the compendia, the analyst should be requirement using an interchangeable method or procedure
aware of the hazards associated with the chemicals and the from one of these pharmacopeias, it should comply with the
techniques and means of protecting against them. These requirements of the USP–NF. When a difference appears, or in
compendia are not designed to describe such hazards or the event of dispute, only the result obtained by the method
O
protective measures. and/or procedure given in the USP–NF is conclusive.
6.20. Automated Procedures 6.40. Dried, Anhydrous, Ignited, or Solvent-Free Basis

Automated and manual procedures employing the same All calculations in the compendia assume an “as-is” basis
basic chemistry are considered equivalent provided the unless otherwise specified.
automated system is properly qualified as being suitable to Test procedures may be performed on the undried or
execute the compendial manual method and the analytical unignited substance and the results calculated on the dried,
procedure is verified under the new equipment conditions. anhydrous, or ignited basis, provided a test for Loss on
Drying, or Water Determination, or Loss on Ignition,
respectively, is given in the monograph. Where the presence
6.30. Alternative and Harmonized Methods and of moisture or other volatile material may interfere with the
Procedures procedure, previous drying of the substance is specified in the
An alternative method or procedure is defined as any individual monograph and is obligatory.
method or procedure other than the compendial method or The term “solvent-free” signifies that the calculation shall
procedure for the article in question. The alternative method be corrected for the presence of known solvents as determined
or procedure must be fully validated (see Validation of using the methods described in á467ñ unless a test for limit of
Compendial Procedures á1225ñ) and must produce comparable organic solvents is provided in the monograph.
results to the compendial method or procedure within The term “previously dried” without qualification signifies
allowable limits established on a case-by-case basis. Alternative that the substance shall be dried as directed under Loss on
methods or procedures can be developed for any one of a Drying á731ñ or Water Determination á921ñ (gravimetric
number of reasons not limited to simplification of sample determination).
preparation, enhanced precision and accuracy, improved Where drying in vacuum over a desiccant is directed, a
(shortened) run time, or being better suited to automation vacuum desiccator, a vacuum drying pistol, or other suitable
than the compendial method or procedure. Only those results vacuum drying apparatus shall be used.
obtained by the methods and procedures given in the 6.40.10. Ignite to Constant Weight
compendia are conclusive. “Ignite to constant weight” means that ignition shall be
For evaluation as a potential replacement or addition to the continued at 800 ± 25°, unless otherwise indicated, until two
standard, alternative methods and procedures should be consecutive weighings, the second of which is taken after an
submitted to USP (see section 4.10 Monographs). additional period appropriate to the nature and quantity of the
10
residue, do not differ by more than 0.50 mg per g of substance Tablets, a counted number of Tablets shall be weighed and
taken. reduced to a powder. The portion of the powdered Tablets
6.40.20. Dried to Constant Weight taken shall be representative of the whole Tablets and shall, in
“Dried to constant weight” means that drying shall be turn, be weighed accurately.
continued until two consecutive weighings, the second of 6.60.20. Capsules
which is taken after an additional drying period appropriate to Where the procedure of a Capsule monograph gives
the nature and quantity of the residue, do not differ by more direction to remove, as completely as possible, the contents of
than 0.50 mg per g of substance taken. not fewer than a given number of the Capsules, a counted
number of Capsules shall be carefully opened and the contents
6.50. Preparation of Solutions quantitatively removed, combined, mixed, and weighed
accurately. The portion of mixed Capsules contents taken shall
6.50.10. Filtration be representative of the contents of the Capsules and shall, in
Where a procedure gives direction to “filter” without turn, be weighed accurately.
further qualification, the liquid shall be passed through
suitable filter paper or equivalent device until the filtrate is
clear. Due to the possibility of filter effects, the initial volumes 6.70. Reagents
of a filtrate may be discarded. The proper conduct of the compendial procedures and the
6.50.20. Solutions reliability of the results depend, in part, upon the quality of the
Unless otherwise specified, all solutions shall be prepared reagents used in the performance of the procedures. Unless
with Purified Water. Solutions for quantitative measures shall otherwise specified, reagents conforming to the specifications
be prepared using accurately weighed or accurately measured set forth in the current edition of Reagent Chemicals published
analytes (see section 8.20 About). by the American Chemical Society (ACS) shall be used. Where
An expression such as “(1 in 10)” means that 1 part by such ACS reagent specifications are not available or where the
al
volume of a liquid shall be diluted with, or 1 part by weight of a required purity differs, compendial specifications for reagents
solid shall be dissolved in, a sufficient quantity of the diluent of acceptable quality are provided (see the Reagents,
or solvent to make the volume of the finished solution 10 parts Indicators, and Solutions section of the USP–NF). Reagents not
by volume. For example, a 1 in 10 solution is prepared by covered by any of these specifications should be of a grade
diluting 1 mL of a liquid or dissolving 1 g of a solid in sufficient
ci suitable to the proper performance of the method of assay or
solvent to make 10 mL of the solution. An expression such as test involved.
“(20:5:2)” means that the respective numbers of parts, by Listing of these reagents, including the indicators and
volume, of the designated liquids shall be mixed, unless solutions employed as reagents, in no way implies that they
otherwise indicated. have therapeutic utility; furthermore, any reference to USP or
6.50.20.1. Adjustments to Solutions NF in their labeling shall include also the term “reagent” or
When a specified concentration is called for in a “reagent grade”. USP may supply reagents if they otherwise
ffi
procedure, a solution of other normality or molarity may be may not be generally commercially available.
used, provided that allowance is made for the difference in
concentration and that the change does not increase the 6.80. Equipment
error of measurement.
Proportionately larger or smaller quantities than the Unless otherwise specified, a specification for a definite size
or type of container or apparatus in a procedure is given solely
O
specified weights and volumes of assay or test substances

and Reference Standards may be taken, provided the as a recommendation. Other dimensions or types may be used
measurement is made with at least equivalent accuracy. if they are suitable for the intended use.
Unless otherwise indicated, analyte concentrations shall 6.80.10. Apparatus for Measurement
be prepared to within ten percent (10%) of the indicated Where volumetric flasks or other exact measuring,
value. In the case in which a procedure is adapted to the weighing, or sorting devices are specified, this or other
working range of an instrument, solution concentrations equipment of at least equivalent accuracy shall be employed.
may differ from the indicated value by more than ten 6.80.10.1. Pipet/Pipette
percent (10%), with appropriate changes in associated Where a pipet/pipette is specified, a suitable buret may
calculations. Any changes shall fall within the validated be substituted. Where a “to contain” pipet/pipette is
range of the instrument. specified, a suitable volumetric flask may be substituted.
When adjustment of pH is indicated with either an acid 6.80.10.2. Light Protection
or base and the concentration is not indicated, appropriate Where low-actinic or light-resistant containers are
concentrations of that acid or base may be used. specified, either containers specially treated to protect
6.50.20.2. Test Solutions contents from light or clear containers that have been
Information on Test Solutions (TS) is provided in the Test rendered opaque by application of a suitable coating or
Solutions portion of the Reagents, Indicators, and Solutions wrapping may be used.
section of the USP–NF. Use of an alternative Test Solution 6.80.20. Instrumental Apparatus
or a change in the Test Solution used may require validation. An instrument may be substituted for the specified
6.50.20.3. Indicator Solutions instrument if the substitute uses the same fundamental
Where a procedure specifies the use of an indicator TS, principles of operation and is of equivalent or greater
approximately 0.2 mL, or 3 drops, of the solution shall be sensitivity and accuracy. These characteristics shall be qualified
added unless otherwise directed. as appropriate. Where a particular brand or source of a
material, instrument, or piece of equipment, or the name and
address of a manufacturer or distributor, is mentioned
6.60. Units Necessary to Complete a Test (ordinarily in a footnote), this identification is furnished solely
Unless otherwise specified, a sufficient number of units to for informational purposes as a matter of convenience,
ensure a suitable analytical result shall be taken. without implication of approval, endorsement, or certification.
6.60.10. Tablets 6.80.20.1. Chromatographic Tubes and Columns
Where the procedure of a Tablet monograph directs to The term “diameter” refers to internal diameter (ID).
weigh and finely powder not fewer than a given number of
11
6.80.20.2. Tubing Institute of Standards and Technology (NIST) standard or

The term “diameter” refers to outside diameter (OD). equivalent. Temperature reading devices may be of the
6.80.20.3. Steam Bath liquid-in-glass type or an analog or digital temperature
Where use of a steam bath is directed, use actively flowing indicator type, such as a resistance temperature device,
steam or another regulated heat source controlled at an thermistor, or thermocouple. Standardization of
equivalent temperature. thermometers is performed on an established testing
6.80.20.4. Water Bath frequency with a temperature standard traceable to NIST. For
A water bath requires vigorously boiling water unless example, refer to the current issue of American Society of
otherwise specified. Testing and Materials (ASTM) standards E1 for liquid-in-glass
6.80.30. Temperature Reading Devices thermometers.
Temperature reading devices suitable for pharmacopeial
tests conform to specifications that are traceable to a National
7. TEST RESULTS
7.10. Interpretation of Requirements each mL of the standardized titrant. In such an equivalence
al
Analytical results observed in the laboratory (or calculated statement, the number of significant figures in the
from experimental measurements) are compared with stated concentration of the titrant should be understood to
acceptance criteria to determine whether the article conforms correspond to the number of significant figures in the weight
to compendial requirements. of the analyte. Corrections to calculations based on the blank
The reportable value, which often is a summary value for determination are to be made for all titrimetric assays where
several individual determinations, is compared with the
ci
acceptance criteria. The reportable value is the end result of a
completed measurement procedure, as documented.
appropriate (see Titrimetry á541ñ).
7.20. Rounding Rules

Where acceptance criteria are expressed numerically herein The observed or calculated values shall be rounded off to
through specification of an upper and/or lower limit, the number of decimal places that is in agreement with the
ffi
permitted values include the specified values themselves, but limit expression. Numbers should not be rounded until the
no values outside the limit(s). Acceptance criteria are final calculations for the reportable value have been
considered significant to the last digit shown. completed. Intermediate calculations (e.g., slope for linearity)
7.10.5. Nominal Concentrations in Equations may be rounded for reporting purposes, but the original (not
Where a “nominal concentration” is specified, calculate the rounded) value should be used for any additional required
concentration based on the label claim. In assay procedures, calculations. Acceptance criteria are fixed numbers and are not
O
water correction is typically stated in the Definition and on the rounded.

label of the USP Reference Standard. For other procedures, When rounding is required, consider only one digit in the
correction for assayed content, potency, or both is made prior decimal place to the right of the last place in the limit
to using the concentration in the equation provided in the expression. If this digit is smaller than 5, it is eliminated and
monograph. the preceding digit is unchanged. If this digit is equal to or
7.10.10. Equivalence Statements in Titrimetric greater than 5, it is eliminated and the preceding digit is
Procedures increased by 1.
The directions for titrimetric procedures conclude with a
statement of the weight of the analyte that is equivalent to
8. TERMS AND DEFINITIONS

8.10. Abbreviations 8.20. About
• RS refers to a USP Reference Standard. “About” indicates a quantity within 10%.
• CS refers to a Colorimetric Solution. If the measurement is stated to be “accurately measured”
• TS refers to a Test Solution. or “accurately weighed”, follow the statements in Volumetric
Apparatus á31ñ and Balances á41ñ, respectively.
• VS refers to a Volumetric Solution that is standardized in
accordance with directions given in the individual
monograph or in the Reagents, Indicators, and Solutions 8.30. Alcohol Content
section of USP–NF. Percentages of alcohol, such as those under the heading
Alcohol Content, refer to percentage by volume of C2H5OH at
15.56°. Where a formula, test, or assay calls for alcohol, ethyl
12
Illustration of Rounding Numerical Values

for Comparison with Requirements
Compendial Requirement Unrounded Value Rounded Result Conforms

Assay limit ≥98.0% 97.96% 98.0% Yes
97.92% 97.9% No
97.95% 98.0% Yes
Assay limit ≤101.5% 101.55% 101.6% No
101.46% 101.5% Yes
101.45% 101.5% Yes
Limit test ≤0.02% 0.025% 0.03% No
0.015% 0.02% Yes
0.027% 0.03% No
Limit test ≤3 ppm 3.5 ppm 4 ppm No
3.4 ppm 3 ppm Yes
2.5 ppm 3 ppm Yes
al
alcohol, or ethanol, the USP monograph article Alcohol shall 8.100. Negligible
be used. Where reference is made to “C2H5OH”, absolute “Negligible” indicates a quantity not exceeding 0.50 mg.
(100%) ethanol is intended. Where a procedure calls for
dehydrated alcohol, alcohol absolute, or anhydrous alcohol,
the USP monograph article Dehydrated Alcohol shall be used.
8.40. Atomic Weights

ci 8.110. NLT/NMT
“NLT” means “not less than”. “NMT” means “not more
than.”
Atomic weights used in computing molecular weights and 8.120. Odor
ffi
the factors in the assays and elsewhere are those established
by the IUPAC Commission on Isotopic Abundances and “Odorless”, “practically odorless”, “a faint characteristic
Atomic Weights. odor”, and variations thereof indicate evaluation of a suitable
quantity of freshly opened material after exposure to the air
for 15 minutes. An odor designation is descriptive only and
8.50. Blank Determinations
should not be regarded as a standard of purity for a particular
Where it is directed that “any necessary correction” be lot of an article.
O
made by a blank determination, the determination shall be

conducted using the same quantities of the same reagents 8.130. Percent
treated in the same manner as the solution or mixture
containing the portion of the substance under assay or test, “Percent” used without qualification means:
but with the substance itself omitted. • For mixtures of solids and semisolids, percent weight in
weight;
8.60. Concomitantly • For solutions or suspensions of solids in liquids, percent
weight in volume;
“Concomitantly” denotes that the determinations or
measurements are to be performed in immediate succession. • For solutions of liquids in liquids, percent volume in
volume;
8.70. Desiccator • For solutions of gases in liquids, percent weight in
volume.
The instruction “in a desiccator” indicates use of a tightly For example, a 1 percent solution is prepared by dissolving
closed container of suitable size and design that maintains an 1 g of a solid or semisolid, or 1 mL of a liquid, in sufficient
atmosphere of low moisture content by means of a suitable solvent to make 100 mL of the solution.
desiccant such as anhydrous calcium chloride, magnesium
perchlorate, phosphorus pentoxide, or silica gel. See also
section 8.220 Vacuum Desiccator. 8.140. Percentage Concentrations
Percentage concentrations are expressed as follows:
8.80. Logarithms • Percent Weight in Weight (w/w) is defined as the number
Logarithms are to the base 10. of g of a solute in 100 g of solution.
• Percent Weight in Volume (w/v) is defined as the number
of g of a solute in 100 mL of solution.
8.90. Microbial Strain
• Percent Volume in Volume (v/v) is defined as the number
A microbial strain cited and identified by its American Type of mL of a solute in 100 mL of solution.
Culture Collection (ATCC) catalog number shall be used
directly or, if subcultured, shall be used not more than five
passages removed from the original strain.
13
8.150. Pressure Molality is designated by the symbol m preceded by a

Pressure is determined by use of a suitable manometer or number that represents the number of moles of the
barometer calibrated in terms of the pressure exerted by a designated solute contained in 1 kilogram of the designated
column of mercury of the stated height. solvent.
Molarity is designated by the symbol M preceded by a
number that represents the number of moles of the
8.160. Reaction Time designated solute contained in an amount of the designated
Reaction time is 5 minutes unless otherwise specified. solvent that is sufficient to prepare 1 liter of solution.
Normality is designated by the symbol N preceded by a
8.170. Specific Gravity number that represents the number of equivalents of the
Specific gravity is the weight of a substance in air at 25° designated solute contained in an amount of the designated
divided by the weight of an equal volume of water at the same solvent that is sufficient to prepare 1 liter of solution.
temperature. The symbol for degrees (°) without a qualifying unit of
measure represents degrees Celsius.
Chart of Symbols and Prefixes commonly employed for SI
8.180. Temperatures metric units and other units:
Temperatures are expressed in centigrade (Celsius)
degrees, and all measurements are made at 25° unless Units Symbol Notes
otherwise indicated. Where moderate heat is specified, any
temperature not higher than 45° (113° F) is indicated. Length
meter m
8.190. Time
centimeter cm
al
Unless otherwise specified, rounding rules, as described in
section 7.20 Rounding Rules, apply to any time specified. millimeter mm
Previously referred to as a mi-

8.200. Transfer micrometer µm cron
“Transfer” indicates a quantitative manipulation. Previously the symbol mµ (for
8.210. Vacuum
“Vacuum” denotes exposure to a pressure of less than
ci nanometer
Ångström
nm
Å
millimicron) was used
Equal to 0.1 nm
Mass
20 mm of mercury (2.67 kPas), unless otherwise indicated.
kilogram kg
ffi
8.220. Vacuum Desiccator gram g
“Vacuum desiccator” indicates a desiccator that maintains a milligram mg

low-moisture atmosphere at a reduced pressure of not more The symbol µg is used in the
than 20 mm of mercury (2.67 kPas) or at the pressure USP and NF to represent mi-
designated in the individual monograph. crograms, but micrograms
O
may be represented as
“mcg” for labeling and pre-
8.230. Water scribing purposes. The term
“gamma”, symbolized by γ,
8.230.10. Water as an Ingredient in an Official Product frequently is used to repre-
As an ingredient in an official product, water meets the sent micrograms in bio-
requirements of the appropriate water monograph in USP or microgram µg chemical literature.
NF. nanogram ng
8.230.20. Water in the Manufacture of Official
Substances picogram pg
When used in the manufacture of official substances, water Also referred to as the unified
shall meet the requirements for drinking water as set forth in atomic mass unit and is
the U.S. Environmental Protection Agency National Primary equal to 1/12 times the mass
Drinking Water Regulations or in the drinking water dalton Da of the free carbon 12 atom.
regulations of the European Union or of Japan, or in the World kilodalton kDa
Health Organization’s Guidelines for Drinking Water Quality.
Additional specifications may be required in monographs. Time
8.230.30. Water in a Compendial Procedure second s
When water is called for in a compendial procedure, the
minute min
USP monograph article Purified Water shall be used unless
otherwise specified. Definitions for other types of water are hour h
provided in Reagents, Indicators, and Solutions and in Water for
Volume
Pharmaceutical Purposes á1231ñ.
1 L is equal to 1000 cm3 (cu-
liter L bic centimeters)
8.240. Weights and Measures
In general, weights and measures are expressed in the deciliter dL
International System of Units (SI) as established and revised 1 mL is equal to 1 cm3, some-
by the Conférence générale des poids et mesures. For milliliter mL times referred to as cc
compendial purposes, the term “weight” is considered to be
microliter µL
synonymous with “mass”.
14
Units Symbol Notes Units Symbol Notes
Tempera- kilo-elec-
ture tron volt keV
Celsius °C mega-elec-
tron volt MeV
Amount of
Substance Radiation
Historically referred to as SI unit of activity for radionu-

gram-molecular weight or becquerel Bq clides
mole mol gram-atomic weight
kilobecquerel kBq
millimole mmol
megabec-
micromole µmol querel MBq
femtomole fmol gigabecquer-

el GBq
Also referred to as
gram-equivalent weight. It is Non-SI unit of activity for ra-
used in the calculation of curie Ci dionuclides
substance concentration in
units of normality. This unit millicurie mCi
is no longer preferred for use
in analytical chemistry or microcurie µCi
equivalent Eq metrology.
nanocurie nCi
al
milli equiva-
lent mEq Other
Osmotic pressure of a solu- acceleration

tion, related to substance due to grav- Used to express rate of centri-
osmole Osmol concentration. ity g fugation
Pressure
milliosmole
pascal
mOsmol
Pa
ci revolutions
per minute rpm
Used to express rate of centri-
fugation
Selected SI Prefixes
Name Symbol Factor
kilopascal kPa
ffi
giga G 109
pounds per
square inch psi mega M 106
millimeter of kilo k 103
mercury mmHg Equal to 133.322 Pa
deci d 10−1
Electrical
O
units centi c 10−2

ampere A milli m 10−3
volt V micro µ 10−6
millivolt mV nano n 10−9
hertz Hz Unit of frequency pico p 10−12
kilohertz kHz femto f 10−15
megahertz MHz
electron volt eV
9. PRESCRIBING AND
DISPENSING
9.10. Use of Metric Units section 5.50.10 Units of Potency (Biological) above]. If an
Prescriptions for compendial articles shall be written to state amount is prescribed by any other system of measurement,
the quantity and/or strength desired in metric units unless only an amount that is the metric equivalent of the prescribed
otherwise indicated in the individual monograph [see also amount shall be dispensed. Abbreviations for the terms
“Units” or “International Units” shall not be used for labeling
15
or prescribing purposes. Apothecary unit designations on 9.20. Changes in Volume

labels and labeling shall not be used. In the dispensing of prescription medications, slight
changes in volume owing to variations in room temperatures
may be disregarded.
10. PRESERVATION,
PACKAGING, STORAGE,
AND LABELING
al
10.10. Packaging and Storage 10.20. Labeling
All articles in USP or NF are subject to the packaging and All articles in USP or NF are subject to the labeling
storage requirements specified in Packaging and Storage requirements specified in Labeling á7ñ, unless different
Requirements á659ñ, unless different requirements are providedci requirements are provided in an individual monograph.
in an individual monograph.
ffi
O

GUID - 8 en-US

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

GUID - 8 en-US

Uploaded by

Copyright:

Available Formats

Printed on: Wed Apr 27 2022, 07:05:23 AM(EST) Official Status: Currently Official on 27-Apr-2022 DocId: 1_GUID-6E790F63-0496-4C20-AF21-E7C283E3343E_8_en-US

GENERAL NOTICES AND

4.10. Monographs........................................................ 6 7.20. Rounding Rules................................................. 11

GENERAL NOTICES AND

2. OFFICIAL STATUS AND

specification, and other requirements related to packaging,

5.20. Added Substances

5.70. Performance Tests as a material standard of reference, a substance meeting all of

6. TESTING PRACTICES AND

protective measures. and/or procedure given in the USP–NF is conclusive.

6.20. Automated Procedures 6.40. Dried, Anhydrous, Ignited, or Solvent-Free Basis

specified weights and volumes of assay or test substances

6.80.20.2. Tubing Institute of Standards and Technology (NIST) standard or

7.20. Rounding Rules

water correction is typically stated in the Definition and on the rounded.

8. TERMS AND DEFINITIONS

Illustration of Rounding Numerical Values

Compendial Requirement Unrounded Value Rounded Result Conforms

97.95% 98.0% Yes

Assay limit ≤101.5% 101.55% 101.6% No

101.46% 101.5% Yes

101.45% 101.5% Yes

Limit test ≤0.02% 0.025% 0.03% No

0.015% 0.02% Yes

Limit test ≤3 ppm 3.5 ppm 4 ppm No

3.4 ppm 3 ppm Yes

2.5 ppm 3 ppm Yes

8.40. Atomic Weights

made by a blank determination, the determination shall be

8.150. Pressure Molality is designated by the symbol m preceded by a

Previously referred to as a mi-

“Transfer” indicates a quantitative manipulation. Previously the symbol mµ (for

“Vacuum desiccator” indicates a desiccator that maintains a milligram mg

Units Symbol Notes Units Symbol Notes

Historically referred to as SI unit of activity for radionu-

femtomole fmol gigabecquer-

Osmotic pressure of a solu- acceleration

units centi c 10−2

or prescribing purposes. Apothecary unit designations on 9.20. Changes in Volume

You might also like