. 2004
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`USP 27
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`NF 22
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`THE UNITED STATES PHARNIACOPEIA
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`THE NATIONAL EQBMULARY
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`UNITED STATES PHARMACOPEIAL CONVENTION, INC.
`12601 Twinbrook Parkway, Rockville, MD 20852
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`which patent or" wademgrk'fi'ghis may ,ex1st-sha11 not hefieemed, and-is not intended as, a grant of, or
`authority to exercise; any:‘r_ig'ht or privilege protected by sfieh'.pate11_,t_of traéeirgai‘k.‘ml s‘ueh fights and.
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`Use ofthe USP—NF is sub]eci: to the terms and cohditions ofthe USPr-NF License Agreement. Attén'tion‘
`is-rcalleci tothe feet that USP and NF text is fully copyrighted. Authors and others wishing to use portions
`of the text should request permission to do so fi'om the Secretary of the USPC Board of Trustees;
`
`Copyright © 2003 TheUnited StatesPhenngoopeial Convention, Inc.
`12601'I‘wh'ibrookl’akaqy,‘Rockville‘,'1VID‘20852’“
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`{fifeneralNoticesand
`Requirements ‘
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`General Notices
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`_ Applymg toStandards Tests
`"-7".Assays and Other Speaficaflons
`ofthe Unlted StatesPharmacopela
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`“Official” and “Official Articles”
`......
`Products Not Marketed in the United States
`Nuln'tional and Other Dietary Supplements .......
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`Atomic Welghts and Chemlcal Formulas
`Abbreviations
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`Abbreviated Statements'in Monographs
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`Significant Figures and Tolerances
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`Equivalence Statements'111 Titrimetric Procedures
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`Toierances
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`Interpretation of Requirements ...............
`General Chapters
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`Pharmaco eial Forum _________________
`Phannacldpeial Previews ...................
`In-Process Revision ......................
`Stimuli to the Revision Process
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`omenclature ..........................
`Interim Revision Announcement
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`Ofl'icial Reference Standards
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`PP ement
`Re
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`USP Reference Standards
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`Deh drated Alcohol """"""""""""
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`Denatured Alcohol
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`Added Substances .......................
`Nutritional and Dietary Supplements ...........
`Additional Ingredients
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`Inert Headspace Gases
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`Colors ...............................
`Ointrnents and Suppositories
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`Tests and Assays ........................
`Apparatus ............................
`Steam Bath
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`Water Bath
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`Foreign Substances and Impurities ...........
`Other I111purities
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`Procedures ............................
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`Odor
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`Pressure Measurements
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`Solutions ...........................
`Specific Gravity
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`Temperatures
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`Time Limit
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`Vacuum .............................
`Water ...............................
`Water and Loss on Drying
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`Test Results, Statistics, and Standaids .........
`Description
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`Solubility ................... ...........
`Interchangeable Methods ._ ...........' ......
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`

`General Notices
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`USP 27
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`Prescribing and Dispensing ...............
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`Storage under Nonspecific Conditions ..... _.
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`Labeling
`Amountgof Ingredient perI DosageUn1It_
`, Use of Leading and Terminal Zeros
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`Labeling of Salts of Drugs
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`='IILabelii1_g VitaminnContaining Products
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`--Lal_)eiing Parenteral and Topical Preparations
`‘ Labeling Elecnolytes
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`Labeling Alcohol
`SpecialCapsules ancl Tablets ' ...... -..........
`Expiration Date and BeyondnUse Date
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`Pharmaceutical Compounding
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`Vegetable and Animal Substances
`Foreign Matter .........................
`Preservation ...........................
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`weights and Measures
`Concentrations
`Percentage Measurements
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`Percent Weight111 Volume ..................
`Percent Volumein Volume
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`Unit—Dose Container
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`Unit—of—Use Container
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`Multiple-Dose Container ......... . ..........
`Storage Temperatureand Humidity ....... ‘.
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`" .. The-General Notices and Requirements (hereinafter referred toss
`the General Notices) and general requirements appearing in General
`:Gh'crptens provide in.surn1nary~form.the-basic guidelines for the
`interpretation and application of the standardsptests,'as'says,‘ and other
`specifications-of thexlbiited States Pharmacopeiaand- eliminate the
`-Iic'ed;to repeat throughout .theboolc those requirements thatare
`pertinent in numerous; instances. Where no specific language: is given
`-to:=:the contrary, -:,the.requirementsunder-a the -‘General- Notices, and
`GenerolChapters apply
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`ii. Whereexceptionsito the-General Notices or General Chapters are
`made, the wording in the individual monograph takes iprec'edenccza'nd
`specifically indicates the directions or the intent. To emphasize that
`such exceptions do exist, the General Notices or General Chapters in
`someplacesemploy where indicated a qualifying expression such as
`:‘i'iunlessotheiwise specified?1 .In .the individual-monographs,i.-'it::_i‘s
`priderstood. that ,thepspecific {Wording .of: standards,-;tests,="assays, and
`other specifications is binding wherever deviations from the General
`Noticespr;General“Chapters-exist'whether or not.
`statement of
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`The full title of this publication, including its supplerrients,:is The
`Eharmacopeia. of_=.the United, States of America, Weary—Seventh
`Revision,-.Ihis title may, beabbreviatedjto imitatedSmtes Phqnnqgo:
`peia, ,‘I-‘wenty—Seventh; Revisionflpr to; USP, 27., fire; Unitgdfitgtes
`fiber-mocopez’o, : .Wenty—Seveuth. Revision,,,.supersedes-gall 7, earlier
`revisions. WherethetermiUSP is used, withoutfilrtller qualification,
`during the period. in which this Pharmacopsia is officialgvit.-r.efersoaly
`to USE- Z-Z-aodany supplemento).theret043’lhe.same titles; with-Loo
`finther distinction, apply equally. to print orelectron-ic presentationof
`rthese contents.
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`reference hereto, . is synonymous with ‘-‘-§Pharn1agop__,l
`“USP”, and with “compendia f’.=
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`' flicia'l title or
`' ""The' designation “USP” in, conjunction with the"
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`elsewhereon mariners an article findicates this
`1 monograph is
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`iiicltided'inithe USP and that the articlegwpzipurpo‘
`to-cdr‘fiply with
`‘an ”applicablegps‘pj; USP standards
`Thekggm designation
`“USPf’Mm, on the label ‘may‘ not alldausrzr does not constitute a
`representation, endorsement, or meorpo'ration by the manufacturer’s
`labeling of the informational ‘material co'ntai'd‘e'd'. in ""the' USP
`moniigraph, nor does it'lconstitutéassurance by USP that the article
`is kniiivn to complyjyith USP standards; 'An article may only purport
`to comply with a USB standard for othéa requirementsggspi; When the
`article; ‘is recognizedfin the USP. The standards apply equally to
`articles healing the‘olli‘ciai titles or names derived by. transposition of
`the defihitive words-of official titles or transposition in the (idler ofthe
`names ,of two orjthore'active' ingredients in ofiicial titles, whether or
`not the":added_desig‘nation.,“USP”, is used. Names considered tohe
`Synonyms of the official titles may not be used for official titles.
`Although both compendia, the- United States Phannacopeia and
`the National Formulary, currently are published under one cover,
`they remain separate compendia.,’,l'he designation USP—NF or similar
`Cambination may be used'on'the’label titan article, provided the label
`also bears a statement such as, “Meets NE standards as, published by
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`thongs? indicating the particular compassion to watching article
`humus to apply."'
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`'Wh' re an. article differs from the standa'ids of st‘r'en'gth,,quality,apld
`Filthy, as determined b‘y'the application, of the assaysqand testsiset
`forth for it in the Bhafinahopeiah its difference shall‘hie' plainlyfstated
`as its tabeL Where an'aififils'failé a comma in. were vine-the
`identity predefined 1n theUiSfifi'oi contains.311: added, substancelhat
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`Articles listed herein are official and the standards set forth inzthe
`monographs apply to' them only when the articles are intended or
`labeled for use as drugs, as nutritional or dietary supplements, or as
`medical devices and when boggling sold,
`‘or dispensed for these
`purposes or when labeled as conforming to this Phannacopeia.
`- -.;:-An article is deemed to bezrecogm'zed inathis Pharmawpeia when a
`monographfor the article is published in it, including-its supplements,
`addenda,onotherintenm revisions, and an official date is generally or
`specifically assigned to it.
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`_,
`,The,.-£ollowing:te_r_ ' ology is used=forgdistinguishing the articles
`for which, monographs are provided; _an ofiicial-substance is an active
`drugieatity, a xeeoefiized, nutrient. a dictalvrsupiilemenf'ingrédient, or
`a--pharmaceutic ingredient (see also; NFV‘ZZ) or a component-of a
`finished; device for which the, monograph title-includes no indication
`.o£_the nature of the finishe‘dffonnpan oficialprepqrotion‘.is—,a_-_dmg
`product, a nutritional supplement dietarysuppienients or- afinished
`device. It is the finished or partially finished ,(e.g.-,=as,in the caseof a
`sterile - solid ;. to; be,,constimted 1 into a solution for padminish'ation)
`preparation or product of one or more officialasuhstalncesformulated
`for use on or for the patient. or. consumer; an articleis an itemfor
`which a monograph is provided,twhether'an official substance, or an
`rectal. variation
`-
`'I‘Desi'gn'aii 'g Conformance, With Qficial Standards—When the
`letters “USP” 01' “NE.” or ‘fUSB7NFi’i' are utilized on the label of: an
`article to indicate compliancewith- compendial standards, theietters
`shallappsarin conjuasaon maths. orfisial title ofthe article of. alien
`appropriate, with ih§.iflglfidi¢fll$. contained therein. The letters are not
`to be enclosed. in any symbol applies. a circle, square, etc., andrnust
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`appear in blockljc‘apital letters... -,
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`If a dietary supplement pp ‘orts to_.,be or IS represented Ins-an
`official product andsuchfciajmis; determined by USP not to be made
`in good faith, it is the policy ofthe. 11:31}, to: seek appropriate legal
`redressivspzz‘
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`Products Not Marketed ii: the United States—Interest in the USP
`outside the-UnitedStatesr-has always-existed. From time. to .‘time,
`monrjgraphs may. beadoptefd for articles not-legally marketed inithe
`United States as a service ”(oz-authoritiesinrother countries where USP
`standards are recognized and : applied.- Appearance of any such
`monograph-'does-notz grant any marketing rights whatsoever, and the
`status ofthe article in the United States must be checked with the US.
`Food and Drug Administration‘in ’the event of any, question.
`Nutritional - and-Other DietaiiyiiSitpjiilerg'zerifsMThe designatioi’i bf
`an oflicial preparation containingone or'rnore recognized nutrients or
`dietary supplementfiflg‘rediehts'Zias': “USP? or
`the use of ;'the
`designation TUSP"? iitiréonjufictionnifii the‘title. 0f such nutritional
`or dietary supplement preparation may be made only if the
`preparation meets AallMs‘m the applicable requirements contained
`inns=indiviaua1'moiiogiaph;ail-djgeii'ei‘at'chaptasfi-‘Any language
`modifying ‘ limiting this iepi‘e'sentationfshall lid'iihc'orripadi‘ed'by-t;
`-'stateitient'indicadhg that thé‘iarticle:is-“not‘USP”, a‘nd indicatihg how
`the article differs nonessential of strength, quality, 'or purity 'a's
`deterifiined hy'the 'applicatidn of the tests and 1i.i's'sa")'r's; set'forth-Iinithe
`compendia.wm, Any additional‘i‘ngredient‘iih subh‘drti‘cle'that has
`recognized in the Phannacopeia and for which nutritional value is
`claimed shall not be represented nor imply that such ingredient is of
`USP uality‘o'r‘iec‘rigni‘z‘e'd :by USP.» :If a preparation ‘do‘es‘ not comply
`with
`allMm, applicable requirements but contains nutrients or
`dietary:supplement ingredients that are-recognized "in the lUSP,' the
`iai‘ti'eie may not designate the l'ia'divi'dmil' nutrients 'ormingriidients“ 'a's
`demplying with USP- sta‘ndards-“or ‘being *ot‘ USPiiqnalityiwithOut
`dedig'iiating‘ on‘thelahel that the article" itself 'doesinot domply'with
`USP standards-‘- " 7' "
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`.‘Th‘e atomiciweights usediin computingmolecular'weightsandr'th‘e
`factors 'in‘ the: aesays‘ and elsewhere. areithose'recomniended‘hl1‘199’?
`by: ‘the TUPAC'JiCOlflI-l‘llssion' ion ‘AtomicmWei'ghts 5and isotopic
`Abundances:iChemical formulas; otherfthan those'i irrthe Definitions,
`tests, and assays, are given for purposes, of‘iint‘ormation and
`calculation. The format withina given monograph is such‘thatafter
`the official title,, the primarily'informational portions (of .the text
`appear first, :followedby the text comprising requirements, the latter
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`

`4
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`General Notices
`
`section of the monograph being introduced by a boldface double-
`arrow symbol >>. (Graphic formulas and chemical nomenclature
`provided as information in the individual monographs are discussed
`in thePr-eface.)-".=
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`. ABBREVIATIONS
`
`
`
`USP 27
`
`a
`
`except where it is indicated otherwise. The use of the molecular
`formula for the active ingredient(s) named in defining the required
`strength of a Bharr'nacopeial article is intended to designate the
`chemical entity Or entities,-as given in the complete chemical name of
`thearticle, having absolute (100 percent) purity.
`-'
`'
`-
`'
`‘
`=
`'
`A dosage form shall be formulated with the intent to provide 100
`percent of the quantity of each ingredient declared on the 1abcl.-'The
`tolerances and limits stated in the definitions in themonographs for
`‘Phannacopeial artieles:.allow. 'for analytical error, for unavoidable
`nariations in'manufacturing and. compounding, and for deterioration
`t6 an extent considered-acceptable under practical conditions. Where
`the minimum amount of a substance present in a nutritional 'or dietary
`supplement is required to beehigher than the .IUWer tolerance limit
`.Iallowedi-for inrthei' monograph -.because of ‘applicable legal
`requirementSythen' the upper- tolerance limit contained iii-the
`monograph shall be increased by a corresponding amount. ,
`'
`-
`The specified tolerarl‘ces are based upon such ttributesof quality
`as might beex‘pected to characterize an article produced from suitable
`raw materials linden-recognized principles of good'manufacturing
`practices -..,
`.-
`.
`-
`s.
`-,
`_.
`The existence of . compendiai"'1imits or tolerances does not
`constitute a basis for a claim that an official substance that more
`nearly approaches 100 percent purity “exceeds” the Pharmacopeial
`quality. Similarly, the fact that an article has been prepared to closer
`tolerances than those specified in the monograph does not constitute a
`a
`basis for a claim that
`the article “exceeds” the Pharmacopeial
`requirements." “ '. ~
`._
`-‘
`.
`.
`Iuieipi‘étafion ofRequireincnrs—Analytical results observed in the
`laboratory (or-calculated 'froin experimental measurements) are
`‘c'ompared with stated limits to ‘- determine whether‘there is
`coh‘fonnance with com’pe'ndial assay or
`test requirements. . The
`observed-"or“calculated-values usually'will contain more significant
`figures than there'a're in the Stated limit, and 'an observed or calculated
`result is to he rounded‘ofl'to the number ofplaces that is’i’n‘ agreement
`withthe’limit'expi‘essiOn'by the-following procedure. [NOTE—Lirnit's,
`which are fixed numbers, are not rounded oft}
`l‘
`-‘
`‘
`. When rounding off is required, consider only one digit in the
`decimal place to the right of the last place in the limit expression. If
`this digit is smaller than 5, it is eliminated and the preceding digit is
`unchanged. If this digit is . greater than 5, it is eliminated and the
`preceding digit-is increased by'one. If this digitequals 5, the 5 is
`.
`)
`eliminated and the preceding digit is increased by one. II
`I
`.
`Illustration a Rounding Numerical "Values for Compaamsf
`
`' with Reflements -;
`"
`f' Compeildiel
`'
`'flnrotinded II Rounded
`,
`_I
`
`..
`Requirement
`Value
`Result
`Conforms;
`IAssaylirditEQSQ‘fi t-
`'193'Q96%;.
`98,0_%
`~ Yes.
`:..
`- 1);
`'-
`'I
`-
`. 91.92%-.-.
`u 919% ;
`, N0. ‘
`97.95%
`“98.0%.,
`Yes .
`101.55%,
`101.6%.
`N?)-
`Ii.01.46%.
`101.5% _
`Yes,
`. _.10Il,45%I
`' _l{)l_,5%
`.Yes,_.<.-_,.I
`,.
`.
`.:
`,Limit-resigo.02% 0.025% f 0.03%.
`:No
`=
`'
`.
`.-
`0.015%
`0.02% ,
`. Yes- .-
`.
`0.027%.._
`.c,03%.
`-.N9..~.
`.
`.
`LimthtestIéB ppm-4..
`:.
`...0.Q003§% ~O.QOO4.% .
`,.-No.gI_.
`.
`.
`=
`0,9002% 10.0003% . “Yes
`,
`
`o.00023% , 010003%- _I..Yes
`“lifts. x.-
`'
`-.
`.
`.
`1
`..
`...-.
`
`'
`
`..7
`
`.
`
`.
`
`-‘
`
`.Assaylimit 5101.5%.
`»
`.
`.
`s
`.
`:
`
`-
`
`.
`
`.
`
`GENERAL CHAPTERS
`
`I. -,IE‘ach\general chapter is assigited'a numberthat appears in brdckets
`adjacent to the chapternam'e (e'.g., (621) Chromatography); General
`"chapters, that. include general requirements for tests and assays are
`numbbred'i'ironifii) to (999), IchIapt'Iei's'that are infdiimationai are
`numbered from (1000) " to' (1999), and chapters pertaining to
`additional supfileriaerits are numbered abeye'{200l))..r,
`‘
`.
`‘
`'The'nse of the general 'chapter numbe‘s' is encouraged for the
`identifieatioIiIi' and rapid access te general testsI'and‘infot-ma'tiongli is
`
`especially helpful Iwhere monograph section headings and en ‘ " ter
`names are not the "same (e,g., Ultraviolet Absorption (197U in '8
`monograph refers to method (1'97U) under general
`tests e aptél
`(197) Spectrophotometric Identification Tests; Specific rotation
`
`\
`
`-
`
`'-
`
`'--
`
`-
`
`I
`
`‘
`
`,
`
`The term RS'i'et‘er's toia’ USP Reference Standard'as stated under
`Reference-Standards in these Geiier‘r‘ri' Notices (seesaw USP
`Refia'rer'zce Standards 5(‘-ll}' for a‘ comprehensive discussion of
`referencematerials).
`__
`'
`_
`‘
`‘
`l
`f‘
`"I
`=
`it
`If
`"
`The terms CS 'and'TS refer '-to Colorimetric-‘Solfltion' and Test
`Solution, respectively r—(See- undeh- Reagents; 'Ihdiéaiorsf and"Solu—
`tioris)[ The term VS refers to-Volumetri Soluti'dn-i'as stated under
`Solutions'in the GciiefalNotices."
`‘
`i t.
`-
`-
`I
`.
`-
`I»
`‘ The term PF 'refers to ‘Phhrmacopcini Forum; 'the journal of
`standards development and official coiii‘p‘endi'a revision (see Phar-
`macapcial Fonmt‘in'these Grafting! Nannies).- " -'
`“
`'
`-'
`-
`:Abbi'eviations: for the names of ir‘iany institutions, organizations,
`'and‘publieations are used for 'convenience‘throughout USP and NF.
`An'alphabeti‘zed tabulation'follows."-'-
`‘
`‘
`.-
`z "
`'
`‘
`institution, Organization, or Publication . . Abbreviation .
`_
`AAMI
`f Association for the Advancement of Medical
`I‘~In'saamenta't.i¢n'
`I
`' "
`.
`American Chemical Society -'-
`..
`.
`'Ameriean‘NationalStandards Institute
`:AOA-C Interhatidnal'tfonnerly Associationiof
`I
`"OlficialAnalyticaIChetnists)
`”
`Americanisoci'etyfor Testing‘a'ri‘d,Materials ‘
`American Type Culture Collection
`'
`ChemicalAbstracts‘Service'
`'
`' UiS. Cdde'ofFederal Regulations
`European'l’harmacopoeia
`US. Environmental Protection Agency
`_ Food Chemicals Codeie '
`'--‘
`'-
`.-
`.
`*U.S.‘IFood and Drug Administration
`
`- 3:.-Health-=lndustry Manufacturers Association
`. International Organizationi‘or
`11‘
`-'
`'
`-
`.- Standardization 2.
`-I
`-: : s «1.:
`. International Union of'Pure and Applied
`=
`':-..'Chemistry J'
`-
`-'
`g "
`Japanese Pharmacopoeia-
`' National, Institute of Standards and
`,
`-.:Technology,.. .I.-
`Z_
`,
`USAN
`5; United States AnoptedNames-w .
`.
`
`.WHO.
`a
`,
`_
`_.
`.
`.World‘l—iealthOrganization-
`--
`I
`.
`--
`--
`
`-
`
`‘
`
`.
`
`-
`
`-
`
`'
`
`'
`
`3
`‘ACS‘
`. ANSI” '
`AOAC-
`'
`'ASTM'
`ATCC .
`CAS
`’
`CFR'
`7' "‘
`EP
`EPA
`'FCCr
`.'FDA
`' HJMA'
`130'
`
`'
`
`-.
`
`.
`
`-
`‘
`
`"
`-'
`
`‘
`
`-
`
`I
`
`V"
`
`'
`‘_‘
`" " '
`'
`
`'
`
`.
`
`:
`
`.-
`
`'-
`
`-
`
`‘
`
`‘
`
`-.
`
`:
`
`..
`.-
`--
`--
`
`-
`
`'
`*IUPAC.‘ .
`'
`" in...
`JP
`-
`-
`"
`.3
`- NIST_-
`'
`
`‘.
`
`z-r‘
`
`,.II 4IbbiI'el’inted Statements in.Monograph'EIncomplete sentences are
`employed in various "portionsofi the monographs-for,directiiess' and
`brevity. Where the limit tests are soabbreviated, it is to,.be understood
`that the chapter'nunibers .' (shown Jill anglea'brgekets} designate the
`respectiveprocedures tofbe' folio Ed, and thatthe values; spe tiled
`afterthe colon.ai'e_the,requiredIIl_irnts.
`p.
`i ..
`
`
`SIGNIFICANT-FIGURES AND TOLERANCE-Sc. .-
`. was has at sinner nutritionists, the' slips" and
`lower limits-of a range _ine1u_de‘.the -two valuesthemselves and: all
`intermediatevalues; but no values. outside the limits; Theilimits
`expressed in monograph definitions and tests, regardless of whether
`the values are expressed as percentages or as absolute numbers, are
`considered significant to the last digit shown.
`Equivalence Statements in Tin‘imetric Procedures—The directions
`for titrimehic proceduresconeiude with a statement of the Weight of
`the analyte that is equivalent to each mL of the standardized titrant. In
`such an equivalenee statement,.it is to be understoedrthat-the number
`of significant figures-in the concentration of the titrant corresponds .to
`the number. of significant figures in the weight ofthe analyte. Blank
`corrections are to be made for: all titrimetric assays where appropriate
`(see liirimetiy (54-1)).
`‘
`-
`'.
`..
`-
`"a ,:-
`,
`Tolerances—Who Ilimits specified in the' monographs "'for
`Pharmacopeial articles are- established With altview- to the ‘use of
`these articles as drugs, nutritional of dietary sdpplements, or'devices,
`
`
`
`
`
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`“USP 27
`
`General'Notices
`
`:5
`
`1(7818) in a monograph refers to method (7818) under general tests
`chapter (781-) 0pt1cclRotat1on,and Calcium (191)111 a mono aph
`refers to the tests for Calcium under general tests chapter 191)
`Identfication RestsmGenemI).
`.
`.
`..
`1
`.,_.1: 1. 1‘
`’.
`.
`."
`.
`3:
`
`PHARMACOPEIA'L FORUM
`
`, Phannacopeml Forum (RF) is the USP journal of. standards
`development and official compe‘ndia'1evisio11. Pharmacopeial Forum
`isthe working document.of. the USP Committee of.Revision. 11'is
`intended..to1 provide publicportions of cominunications- within the
`General Committee of Revision and p1ublicnotice of proposed new
`'and revised standards ofthe USP and NE and to afford opportunity
`.1111. comment thereon. The organization of PF includes, but'is not
`limited to, the followingsections. Subsections occurwhere needed
`for Drugs and Phann'aceutic Ingredients (Excipients) and tin
`Nutritional supplements
`- Pharmacopeiol P1evrews—Posmble revisions 01 new monographs
`01- chapters that are considered to be in a preliminary stage of
`development
`.
`,[-In-P1ocess Rewsron—New or revised monographs or chapters that
`are proposed foi adoption-as officialUSP or NF standardsu
`'
`:Stimuli to the RevisionP1mess—Reports statements, articles, or
`Commentaries relating to crimpendial'issues.
`omencluture—Articles and announcements relevant to
`1.
`
`compendial nomenclatureIssuesand listings of suggested and new
`United States Adopted Names (USAN) and International Nonpro-
`prietary Names
`Interim Revision Announcement (fpresenflioffimal revisions
`"arid their eflfectivé' dates, announcement of the availability of'new
`USPReference Standards, andannouncement of assays or tests,that
`gs: hdeldain abeyance pending availabihty ofrequired USP Reference
`tan ar 3
`'
`Ofieiol Reference StandardsmCatalog of current lots of. USP
`Reference Standards With ordefing. information and names and
`addresses _of worldWide suppliers.
`-
`
`51111111111111»
`
`' Simplerniz'nts to -cflic_ial'.'t'ext'_are published periodically ,randineltide
`1
`1
`text previously published 1111:1317, which-is ready to be made ofiicial.
`
`
`RE-AGENT STANDARDS
`The proper conduct ofthePharmacopeial-.tests and assays and the
`reliability of the results depend, in part, upon the quality of the
`reagents used'In the performance of the procedures. U-nless otherwise
`specified reagents are to be used that conform to the specifications set
`.forth'1n the current edition of Reagent Chemicalspublished by the
`American Chemical Society Where such ACS reagent specifications
`are not availableor where for various reasons the required. purity
`differs, compendial speCifilcations' for reagents of acceptable quality
`are provided (seeRed'genfs,‘ Indicators, mid Solutions) Listingof
`these reagents, including the indicatms and solutions employed as
`reagents,
`in no way implies.
`that
`they have therapeutic utility;
`fiiithcimore, any 1efere'11ce to USP or NF'in their' labelingshall
`Include also the term “reagent” 'or‘reagent grade '
`'
`-
`1-.
`
`
`REFERENCEREAGENTS"" '
`Some c‘ompendial tests. or assays require the use of specific
`reagents. These are supplied by U'SP' When they might not. be
`generally commercially availablt':yorbecause they are necessary for
`Elietestingandare available only to theoriginator ofthe tests orassay
`“3"
`.
`'
`1
`.
`:
`.'
`1‘.
`'31"
`3"1'
`
`I
`
`USPREFERENCE STANDARDS.
`USP Reference Standards areauthentic specimens.that have been
`approved _by the USPReference Standards Committee as suitable for
`use as comparison standards'in USP 01 NF tests and assays. (See USP
`Reference Standards {1 '1).) Currently official lots of USP Reference
`Standards are published'in P111111macopemlFomm
`Where a USP Reference Standardis referred to in a monograph or
`chapter, the Words._“1Reference Standard” are abbreviated to “RS”
`(see USP Rejferenoe Standards (11))
`.
`.
`Where a test or an assay calls for theuse ofa compendialarticle
`ratherthan £01 a USP ReferenceStandard as a material standard 'of
`reference, a substance meeting all of the Icompe'hdial monograph
`requirements for that article'is to be used
`‘
`:Tli'e requii‘emehts forany new' USP 01‘ NF standards, tests, or
`assays for which a new USP Reference Stapdardis specified are not
`in effect until the specified USP Reference Standard'is available. The
`availability ofnewUSP Reference Standards and the officialdates of
`the USP 01' NF standards, tests, or assays requiring their use are
`announced via Supplementsor 1111131711111 Revision Announcements.
`
`UNITS OF POTENCY
`that cannotbe completely characterized _hy
`For substan'Ces'
`chemical and physical means,
`it. may be necessary to express
`quantifies ofactivity inbiologioa'lunits ofpotency, each defined by an
`authoritative, designated reference, standard.
`-Units of biologibal potency defined by the World Health
`Organization (WI-IQ) for hiternational‘ Biological Standards and
`International Biological Reference Preparations are terrned Intema-
`tional Units (1U) Units definedby USP Reference Standards are. USP
`Units, and the individualmonographs refer to these. Unless otherwise
`indicated; USP Unitsare equivalent to. the corresponding Interna-
`tional Unit's, where such exist. Such'lequiValchlQé is. usually
`established on the basis solely of the compendial assay for the
`substance
`‘
`For biologicalproducts, whether ornotInternationalUnits or- USP
`Units do exist (see Biologics (1041)), units ofpotency are.definedby
`the co1resporiding US Standard established .by'the FDA.
`-
`Change to read:
`
`INGREDIENTS_AND PROCESSES
`Ofiicial ‘drug products and finisheddevices are prepared from
`ingredientsthat meet therequirements ofthe compendi'al monographs
`for those individual ingr'edients for 11111611 monographs are provided
`(see also NF 22): Generally,nutritional and dietary supplements are
`prepared fiom ingredients that meet requirements of the compendial
`monographs for thoSe ingredients for Which monographs are
`provided, except thatsubstances of acceptable food. grade quality
`'may' betitiliZed'1nthe event of a difference.
`_
`Ofiicial substances.are prepared accordingto 'recog'niz'ed'principles
`'of good manufacturing practice'and from ingredients complying with
`speclficatlons designed to assure that the' reshl't'a'nt Substances meet
`'lh'e'requirements of the coinpendial monographs (see 'al'so Foreign
`Sdbsian'ces 'and Inmdrt'ties under Tests andAssays).
`Preparations for which a completecompositionis'given in this
`Pharinacope'ia, unless specifically exempted herein _01
`in the,
`individual monograph;are to contain only the ingredients 'named'in
`the females. However, there may bedeviation fiom the specified
`processes or methods of"compounding,“ though not- fi‘om the
`ingredients in prdp'ortidns' thereof, providedthe' finished preparation
`Conforms to the relevant standards laid down- herein and to
`preparations produced- by following the specified process.
`- -“"
`i The tolerances specified in individual monographs and in the
`general chapters for- compounded preparations arebased on those
`attributes of quality as might- be1 expected to characterize an article
`compounded from suitable bulkdrugsubstances and ingredients'in
`accordance with the procedures provided 01-underrecognized
`principles of good pharmaceutical practice as described in this
`Phannacopeia (see.Pharmaceutical Compounding—Nonsterile
`Preparationswm, (795)))-andelsewhere-.1
`.Monographs'for prepaiationsintended to‘be compounded}:ursti'a'nt
`to prescription may containassay methods;- Assay methods are not
`intended for evaluating a compo