Scribd Logo
Upload

Welcome to Scribd!

  • Usp 41 NF 36 Volume 5part1 1600 PDF - Gdrive.vip

    Uploaded by

    azedaa
    343 views181 pages

    Original Title

    Usp 41 Nf 36 Volume 5part1 1600 PDF.gdrive.vip

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    343 views181 pages

    Usp 41 NF 36 Volume 5part1 1600 PDF - Gdrive.vip

    Uploaded by

    azedaa

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 181
    2018 USP. 41 | THE UNITED STATES PHARMACOPEIA NF 36 THE NATIONAL FORMULARY Volume 5 By authority of the United States Pharmacopeial Convention Prepared by the Council of Experts and its Expert Committees Official from May 1, 2018 The designation on the cover of this publication, “USP NF 2018,” is for ease of identification only. The publication contains two separate compendia: The United States Pharmacopeta, Foty-Frst Reviion, and The National Formulary, Tity-Sxth tion THE UNITED STATES PHARMACOPEIAL CONVENTION 12601 Twinbrook Parkway, Rockville, MD 20852 SIX-MONTH IMPLEMENTATION GUIDELINE The United States Phormacopeia-Notional Formulary and its supplements become official six months after being released to the public. The USP-NF, which is released on November 1 of each year, becomes official on May 1 of the following year. This sichonth implementation timing gives users more time to bring thelr methods and procedures into compliance with new and revised USP-NF requirements ‘The table below descibes the offical dates of the USP-NF and its supplements. The 2017 USP 40-NF 35, and its supple- ‘ments, Interim Revision Announcements (IRAs) and Revison Bulletins to that edition, will be official until May'T, 2018, at which Ume the USP 41-NF 36 becomes official. Publication “Release Date Official Date ‘Official Until, USP 41-NE 36 November 1, 2017 | May 1, 2018 May 1, 2019 (Gxzept a superseded by supplements, RAs, and Revisor Bulletin) Vist Supplenentto the | February 1,2016 | August 1, 2018 | May 1, 2019 (except ws superseded by Second Supplement RAs, 2 ATONE ‘and devision Buleti Second Supplement tothe | June 1, 2018 ] December 1, 2018 | May 1, 2019 (except as superseded by RAS and Revi Buetins USP 41-NF 36 USP 42-NE37 November 1, 2018 | May 1, 2019 ‘ay 1, 2020 (except a superseded by supplements, RAs, and Revision Bulletin) ‘The table below gives the details of the IRAs that will apply to USP 47-NF 36. [ira T Pr Postina Date | Comment Due Date | IRA Posting Date JRA Official Date act) January 2, 2018. March 31, 2018. May 25, 2018 uy 1, 2018 442) March 1, 2018 May 31,2018 uly 27, 2018 Sepiember 12018 4403) May 1, 2018 uly 31, 2018 September 28, 2018 Noverrber 1, 2018. (4) ly 2, 2018 eptember 30,2018 ‘November 23, 2018 Ianwary 1,201 44051 [September 4, 2078 _|_November 30, 2018 | January 25,2019___| March 1, 2019 44(6) Novernber 1, 2018 January 31, 2019. March 29,2018 May 1, 2012 Revision Bulletins published on the USP website become official on the date specified in the Revision Bulletin. NOTICE AND WARNING Concerning U.S. Patent or Trademark Rights—The inclusion in The United States Pharmacopeia or in the National Formulary of a monograph on any drug in respect to which patent or trademark rights may exist shall not be deemed, and is not intended 4s, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express permission, authorty, or license secured from such patent or trademark owner. Concerning Use of USP or NF Text—Attention is called to the fact that USP and NF text is fully copyrighted, Authors and cathers wishing to use portions of the text should request permission to do so from the Secretary of the USPC Board of ‘Trustees, Copyright © 2017 The United States Pharmacopeial Convention 12601 Twinbrock Parkway, Rockville, MD 20852 Ath curt (ssNP01 95-7996 ISBN: 978-1-936424-70-2 Printed in the United States by United Book Press, Inc, Baltimore, MD USP 41-NF 36 VOLUME 1 Mission Statement and Preface ...... vi People 2015-2020 Revision Cycle .....xi Officers oxi Board of Trustees xi Council of Experts. . xi Expert Committees . xi In Memoriam Members of the United States Pharmacopeial Convention, as of May 31, 2017... 2016 Recognition of Mono ap and Reference Material Donors ... xvi Articles of Incorporation . sav USP Governance tie Bylaws xix, Rules and Procedures wxiX USP Policies = Wxix Admissions ..... + ax Astices Admitted to USP 41 by Supplement ...... year oxi New Articles Appearing in USP 41 That Were Not included in USP 40 Tncucng Supplements . xxiv Articles Included in USP 40 But Not Included in USP 41 . «XXXIV Annotated List XVI Notices General Notices and Requirements .........4 3 Contents iit Contents Guide to General Chapters cs Monographs Official Monographs for USP 47, Acl......... 19 Index Combined Index to USP 47 and NF 36. . 4 VOLUME 2 Notices General Notices and Requirements ........... Guide to General Chapters . Monographs Official Monographs for USP 41, |-Z - 2303 Index Combined Index to USP 47 and NF 36....... 11 VOLUME 3 Notices General Notices and Requirements Guide to General Chapters .......... xix I S acs iv Contents Global Health Official Monographs - 4415 Dietary Supplements Official Monographs = 4417 NF 36 Admissions Atticles Admitted to NF 36 by Supplement .. 5167 New Articles Appearing in NF 36 That Were Not Included in NF35 Including Supplements . - 9167 New Articles Appearing in NF 36. - 5167 Annotated List... 5168 Excipients USP and NF Excipients, Listed by Category - 5169 Monographs Official Monographs for NF 36 5179 Index Combined Index to USP 47 and NF 36 VOLUME 4 Notices General Notices and Requirements ix Guide to General Chapters . si we KM Reagents, Indicators, and Solutions ... ee + 5659 Reagent Specifications » 5664 Indicators and Indicator Test Papers... 5745 USP 41-NF 36 Solutions... 5748 Buffer Solutions . 5748 Colorimetric Solutions . . . 5749 Test Solutions ....... 5750 Volumetric Solutions . . $761 Chromatographic Columns . 5774 Reference Tables Containers for Dispensing Capsules and Tablets. . 5781 Description and Relative Solubilty of USP and NF Articles $791 Approximate Solubilties of USP and NFAtticles ........+. aE 5851 Atomic Weights = 5859 Half-Lives of Selected Radionuclides . - 5860 Alcoholometric Table... .. 5861 Intrinsic Viscosity Table 5863 General Chapters See page xit for detailed contents General Tests and Assays sors General Requirements for Tests and Assays .. 5915 Apparatus for Tests and Assays 5954 Microbiological Tests... .- 6 60eeee00 - 5959 Biological Tests and Assays... + 5991 Chemical Tests and Assays 6094 Physical Tests and Determinations .. 6327 Index Combined index to USP 47 and NF 36 bd VOLUME 5 Notices General Notices and Requirements... . ix USP 41-NF 36 Guide to General Chapters General Chapters See page 63 ior detailed contents General Information . Perret treet 6699 Dietary Supplements . Contents v . 8153 Index Combined Index to USP 41 and NF 36. Fev es usP 41 General Notices vil General Notices and Requirements Ap plyin Assays, ani to Standards, Tests, Other Specifications of the United States Pharmacopeia 1. Title and Revision 2. Official Status and Legal Recognition 2.10, Oficial Text: «| 2:20, Official Articies 2'30, Legal Recognition 3. Conformance to Standards 3.10, Applicability of Standards 3.20. Indicating Conformance 4. Monographs and General Chapters 4:10, Monog hs : 420 Genel Copier: 5. Monograph Components Mdecubr Formula Added subsances scription and Solubility Identfcation " Assay Imparitiés and Foreign Subst Performance Tests USP Reference Standards Testing Practices and Procedures 6.10, Sate Laboratory Practees . === 6:20, Automated Procedures 8°30, Alternative end Harmonized Methods and Procedures 6.40, Dried, Anhydrous, ignited, of Solvent- Free Basis xi xi xi coe 6.50. Preparation of Solutions tiv 8:0, Uns Recessay fo Compe seit 670. Reagents. ov 880: Equipment oh 7. Test Results . x 716: hierpretation of Requicmncnis ~ 7.20. Rounding Rules - ~ . Terms and Definitions ” “Abbreviations ~ B20. About ~ 830. Alcohol Contené 22210200) 0.0 IN ” 840: Atomic Weights w 850. Blank Determinations " 850. Concomtantiy mM 870. Deskeator s 220202201 wi 820: Logarithms mM 850, Karoo Stain Pe S100, M 8110. Lot 8120. mt 8130. eaeaemecss ae erentage Conceniraons ot 8150. Presure = re 140, Roaton Fr et £100. temperatures, wi 8.190. Time 8.200. Transfer’ mt 8210. Vacuum Loe 820. Vacuurn Desceator et 8.230, Water vo 8.240. Weights ond Wasa 12002) 200 00001 ml a ” 2 a Pa = 3 ce cS o rc) viii General Notices Prescribing and Dispensing .10 Use of Matric Units 9:20 Changes in Volume usp 41 xii 10, Preservation, Packaging, Storage, xa and Labeling wi yell 01D. Packaging and Storage ...0.. 21... bees ail 10,20: Labeling ait usr 41 General Notices ix GENERAL NOTICES AND REQUIREMENTS The Generol Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and de- fault conditions for the interpretation and application of the Unted States Phamacspee US) and the National Frmulary Requirements stated in these General Notices apply to all articles recognized in the USP and NE (the compendia”) and to all general chapters unessspeccally stated otherwise 1. TITLE AND REVISION “The ful title ofthis publication (consisting of fve volumes and including its Supplements), is The Pharrmacopeia of the United States of America, Forty-irst Revision and the Na- tional Formulary, Thirty Sith Edition. These titles may be ab- breviated to USP 47, to NF 36, and to USP 41-NF 36. The United States Pharmacopeia, Forty-First Revision, and the Na- tional Formulary, Thiry-Sixth Edition, supersede all earlier re- Visions. Where the terms “USP,” "NE," or “USPLNE" are used without further qualification during the period in whch these compendia are offical, they refer only to USP-47, NE 36, and any Supplement(s) thereto. The sarne tiles, with no further distinction, apply equally to print or electronic pres- entation of these Contents Although USP and INF are pub- lished under one cover and share these General Notices, they are separate compendia. This revision is offical beginning May 1, 2018 unless oth- cenwise indicated in specific text. Supplemenssto USP and NF are published periodical ‘Accelerated Revisions, publisned periodically on the Orf- Gil Text section cf USP's webste (itp|Iww.usp orgs. Ifotticial-text, are designed to make revisions cffciel more guickly than through the routine proces for publishing Standards in the USP-NF. Interim Revision Announcements are ‘Accelerated Revisions to USP and NF that contain official re- Visions and their effective dates. Revision Bulletins are Accelerated Revisions to official text or postponements that require expedited publication. They generally are official immediately unless otherwise specified in the Revision Bulletin. Errata are Accelerated Revisions representing corrections totems erroneously published. Annourcerents ofthe aval abilty of new USP Reference Standards and announcements Of tests or procedures that are held in abeyance pending avalabilty of required USP Reference Standards are also available on the "Official Text” tab of USP's website. 2. OFFICIAL STATUS AND LEGAL RECOGNITION 2.10, Official Text Oficial text of the USP and NF is published in the USP-NF Onine (www.uspnf.com) in the edition identified as “CUR- RENTLY OFFICIAL” and in Accelerated Revisions that super- sede the USP-NF Online as described below. Routine revisions are published in the USP-NF Online and become official on the date indicated, usually six months after publication. Accelerated Revisons supersede the UsP-NF Online and become offical on the date indicated Links to Accelerated Feisons on the USP website can be found in any superseded monograph or general chapter in the USE-NP One oepne * Print and USB fash drive versions of the USP and NF also are available, Routine revisions are provided with the same timing 2s the USP-NF Online. Official text published in Sup pleménts supersedes that in the previously published print or Use flash drive vesions of USP-NF. Thess versions aso are Siperjeded by Aceeeraled Revisor as Gescrbed above fring crart of any spar between the pnt or USE fish dive versons and the USP-NF One, the USP-NF On Therwil be deere opp. 220, Official Articles Ar seal erie son arte that is recognized in USP or Ne An aricle b deemed fo be recognized and induded fra craps where mronegrerh fore arte & published in'te compendium and an ofal date b-generaly orspe- Shealy cobeed ts tne rmcromeeh "he tile Spectied n'a moncgraph i the oficial tle for sh Ak cater pahes capebicta tate srcnyr ta Sil tes may rot be used assubsttutes for offal thes (il ere ince both oficelsubsoncrs and oft! products neff substance is 2dr substance, excipient, Foray birutane oie merece ecient ott ished devee for which the monograph te includes no ince Goh ef te nature ofthe shee erm ‘An offal produc \s2 cru produc, dietary supplement, compourded preparation, of ished device or Pics monograph is prowded 230. Legal Recognition ‘The UM? and NP are recognized inthe laws and regula tio of ay counties trecdiout ine word. Reauta tutesiics re enforce the six cary preset ithe ad, but because recognition of he USP and may {ary by county, srs shoud understand appeal as 2 ulti nthe Unis Sates ange the Feder Food, Drug, and Cosmetic Act (FDCA), both USP and NF are IScognzed aoc amped. A arog witha mae ec ged in USPeNF must Comply with compendia derby SEndards of be deemed adulterated, misoranded, or both. See, €.g., FDCA § 501(b) and 502(e)(3)(b); also FDA regula- tons, 21” CFR § 299,5(@8b). To avoid being deemed adulterated, such drugs must also comply with compendial Sandards for srengty qualty, and purty, unless abel fo Show all espects nvwhh the drug afer. See, e., FCA §'501(b) and 21 CER § 299.5(0). In addition, to avoid being eomed misbranded. drugs recognized in USP

    You might also like