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`REPLACEMENT EXHIBIT 2023 
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`REPLACEMENT EXHIBIT Z023
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`NOVARTIS EXHIBIT 2023
`Noven v. Novanis and LTS Lohmann
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`Page 1 of 19
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`

`
`Second Su
`
`The United States
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`Pharmacopeia
`'l'H/R TY-F0 UR TH RE VISION
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`The National
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`Released June 1,2011
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`()t'ficiaI December I. 20! l.cxceptwhereotlierwise tinted
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`[iv cm!/1oI‘1'I_,it Q/'1/ic United States‘ P/icI/'Iiicrc‘opc'i(i/ Coiive/it/"mi (USP).
`I’/‘epured by I/to (foitiicil Q/'I;',\‘pm'fs (1/Ic/pit/J/1'.w/zed /)_V the Board Q/’TI'ii.s'Icc>.s‘.
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`Duane M. Kirking, I’liarm,[)., Pl‘i.D.
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`Tliis Supp/cmcni coniprises revised and new text pertiiiiiiiig to l/SP J4 —iV/"29.
`lMI’0R'I'/\NT —Save the SovomlSit/2];/eniwzr and all succeeding, Sllpplclilcltls. C1iaiige~; and additions listed in the Sci-oiid Sit];/2/mite/it ate etleetive from
`December 1, 201 1, except where otherwise tinted.
`
`Publication
`
`USP 34-NF 2‘)
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`["ii‘.s't Supplement
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`Seeoiid Supplement
`
`Proposed
`I RA*
`
`PI" 37 (ll
`.laiiuai'y 201 I
`
`P1‘ 37 (21
`March 2011
`
`PI‘ 17(1)
`May 2011
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`PF 37 (4)
`July 2011
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`PF 37 (5)
`September 2011
`PI" 37 (6)
`November 201 1
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`Publish Date
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`Official Date
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`Noveiiiber I, 21110
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`May I, 2011
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`May 27, 201 1
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`July 1, 2011
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`/\L|g,lI_‘Il 1, 2011
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`July 20, 201]
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`September 1, 201 1
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`September 3()_ 2011
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`November 1, 201 1
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`June 1,2011
`
`December I, 201 I
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`November 30, 20] I
`
`.Iaiiuary I. 30 l 3
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`January 27, 2012
`
`March 1.2012
`
`Marcli 30, 2012
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`May 1,2012
`
`Incorporated
`into
`
`131 Supplement
`to USP 34—NI* 24)
`
`LISP 35—I\1'3()
`
`Ind Siipplcmeiit
`to USP 34-N1~2‘)
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`lSI Supplement
`to USP 35—:’\II" 30
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`1st Supplenient
`tnUS1’ 1S—\11‘
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`USP 3(7—Nl" 31
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`* Interim Revision Announcements (IR/\s) are proposed in [’/zui'niuw/)c/'a/ Forzmi and become official on the USP Web site.
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`‘D201 1 The United States Pharmacopeial Convention. 12601 Twinbrook Parkway, Rockville, MD 20852. All rights reserved. \Io part oftliis
`publication may be reproduced. stored in zi retrieval system, or transniittcd in any lorni, or by any means including electronic, mccliaiiical.
`photocopying, recording, or otherwise without prior permission o lthe USP.
`
`ISSN ()|t)5-7<)()fi
`/I // 1'1};/1I.\' re.s‘ervecI'.
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`atthe NLM and may be
`SL1 l}jI'-_|II‘lZ US Copyright Laws.
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`Printed in the United States
`
`

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`Second Supplement to USP 34—NF 29
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`Contents 5061
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`Contents
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`People
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`Officers (2010-2015)
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`Board of Trustees (2010e2015) .
`Council of Experts (2010-2015) .
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`New Articles Appearing in This Supplement
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`Introduction .
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`This n1 ate rial was copied
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`

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`5062 Contents
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`Second Supplement to USP 34_NF 29
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` ____
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`Excipients
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`Monographs, USP 34
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`|-1
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`This materialwasmpied
`atthe NL|'-:1 and may be
`Eu I:-jett US Copyright Laws
`
`

`
`5070 Annotated List
`
`Second Supplement to USP 34—NF 29
`
`ANNOTATED LIST
`
`Monographs, General Chapters, Reagents, and Tables Affected by Changes
`Appearing in This Supplement
`
`Page citations referto. the pages of this Su plement. l\_lote—ln the table below, if a section is new or if a subsection is added to
`or deleted from an existing section, it IS lpbe ed as such in parentheses after the section or subsection name. items on this list that
`appear without the designation new,
`added, or deleted,” are items in which changes have been made to existing official text.
`
`General Chapters
`
`General Tests and Assays
`
`Other Tests and Assays
`(413) Impurities Testing In Medical Gases, 5087 (new)
`(415) Medical Gases Assay, 5087 (new)
`Physical Tests and Determinations
`(711) Dissolution, 5090
`Apparatus (subsection Apparatus I, Figure 1)
`(905) Uniformity of Dosage Units, 5097
`Introduction
`Content Uniformity
`Criteria
`
`General Information
`
`(1027) Flow Cytometry, 5100 (new)
`(1046) Cellular and Tissue-Based Products, 5112
`(1047) Gene Therapy Products, 5135 (new)
`
`Dietary Supplements
`
`(2040) Disintegration and Dissolution of Dietary Supple-
`ments, 5159
`Dissolution
`
`Reagents, Indicators, and Solutions
`
`Reagent Specifications
`Deuterium Chloride, 5188 (new)
`2-(Dimethy|amino)ethyl Methacrylate, 5192
`Dulcitol, 5194 (deleted)
`Hexamethylenetetramine, 5199 (new)
`Methenamine, 5204
`Methylene Blue, 5206
`Perchloric Acid, 5212
`4-(2—Pyridylazo)resorcinol, 5218 (new)
`Silica Gel, 5220
`Sulfamerazine, 5228 (new)
`Trifluorovinyl Chloride Polymer, 5233
`Test Solutions
`Ammonium Carbonate TS 2, 5241 (new)
`Methoxyphenylacetic TS, 5245 (new)
`Sodium Hydroxide TS 3, 5247 (new)
`Chromatographic Columns
`L75, 5259 (new)
`
`Reference Tables
`
`Container Specifications for Capsules and Tablets
`Crypthecodinium cohnii Oil Capsules, 5262
`
`Escitalo ram Tablets, 5263
`Schizoc ytrium Oil Capsules, 5267
`Topiramate Ca sules, 5268
`Trandolapril Ta lets, 5268
`Valacyclovir Tablets, 5268
`Vitamin A Tablets, 5268
`Zaleplon Capsules, 5269
`Descrip
`tion and Relative Solubility of USP and NF
`Articles
`Chitosan, 5281
`Diclofenac Potassium, 5286
`Etomidate, 5290
`Leflunomide, 5298
`Piperacillin, 5309
`Polyglyceryl Diisostearate, 5311
`Racemethionine, 5315
`Hydroxypropyl Corn Starch, 5319
`Hydroxypropyl Pea Starch, 5319
`Hydroxyprop I Potato Starch, 5319
`Trospium Ch oride, 5324
`Zaleplon, 5326
`Excipients
`Antioxidant
`Racemethionine, 5355
`Buffering Agent
`Racemethionine, 5356
`Coating Agent
`Chitosan, 5356
`Emulsifying and/or Solubilizing A ent
`Po|y|cerl3D"
`t
`t,
`35
`Film-Fo_r?niyng Agentusos eara e
`7
`Chitosan, 5357
`Flavors and Perfumes
`Racemethionine, 5357
`Ointment Base
`Polyglyceryl 3 Diisostearate, 5357
`Suspcezrnictlgrggnansda/gag Viscosity-Increasing Agent
`Hydroxylpropyl Corn Starch, 5358
`Hydroxy ropyl Pea Starch, 5358
`Hydroxy propyl Potato Starch, 5358
`Tablet Binder
`nygroxylpropyllCorgtSta]r‘ché35359
`roxy ropy
`ea
`arc ,
`59
`Hydrox propyl Potato Starch, 5359
`Tablet and or Capsule Diluent
`Hydroxylpropyl Corn Starch, 5359
`Hydroxy ropyl Pea Starch, 5359
`Tabllélt)/gr‘o_x); prop): Potato Starch, 5359
`isin egran
`Hydroxylpropyl Corn Starch, 5359
`Hydroxypropyl Pea Starch, 5359
`_H droxy propyl Potato Starch, 5359
`Vehic e
`SOLID CARRIER
`Chitosan, 5360
`
`This material was {U-Q“-lEd
`E‘t“l‘l'l~E NLM and may‘ l}vE
`Subject U555-pyright Law-5
`
`

`
`Second Supplement to USP 34—NF 29
`
`Annotated List 5071
`
`Monographs (Dietary Supplements)
`
`Monographs (USP 34)
`
`Bacopa, 5327 (new)
`Powdered Bacopa, 5328 (new)
`Powdered Bacopa Extract, 5330 (new)
`Centella asiatica, 5331 (new)
`Powdered Centella asiatica, 5333 (new)
`Powdered Centella asiatica Extract, 5334 (new)
`Centella asiatica Triterpenes, 5336 (new)
`Crypthecodinium cohnii Oil, 5337 (new)
`Crypthecodinium cohnii Oil Capsules, 5339 (new)
`Garcinia cambogia, 5342 (new)
`Powdered Carcinia cambogia, 5343 (new)
`Powdered Garcinia Hydroxycitrate Extract, 5344 (new)
`Carcinia indica, 5345 (new)
`Powdered Garcinia indica, 5347 (new)
`Glutathione, 5348 (new)
`Schizochytrium Oil, 5349 (new)
`Schizochytrium Oil Capsules, 5352 (new)
`
`Monographs (NF 29)
`
`Chitosan, 5361 (new)
`Crospovidone, 5365
`DEFINITION
`IDENTIFICATION
`Test C (added)
`Test D (added)
`IMPURITIES
`Residue an ignition
`Peroxides (added)
`Vinylpyrrolidinone
`SPECIFIC TESTS
`
`.
`pH (deleted) _
`Water Determination (deleted)
`Loss on Drying (added)
`Water-Soluble Substances (subsection Acceptance
`criteria)
`ADDITIONAL REQUIREMENTS
`Labeling (added)
`Hypophosphorous Acid, 5366
`IDENTIFICATION
`Identification Tests——General, Hypophosphite
`(deleted)
`Test A (added)
`Test 8 (added)
`Maleic Acid, 5367
`IDENTIFICATION
`Infrared Absorption
`Polyglyceryl 3 Diisostearate, 5368 (new)
`Polyoxyl Lauryl Ether, 5369
`CHEMICAL INFORMATION
`IDENTIFICATION
`Test C (added)
`IMPURITIES
`Organic Impurities (subsection Procedure: Limit of
`Free Ethylene Oxide and Dioxane)
`ADDITIONAL REQUIREMENTS
`USP Reference Standards
`Prop Iene Glycol Dicaprylate/Dicaprate, S370
`SYPECIFIC TESTS
`Fats and Fixed Oils, Saponificatiori Value
`Racemethionine, 5370 (new)
`Sorbic Acid, 5372
`IDENTIFICATION
`Infrared Absorption
`ADDITIONAL REQUIREMENTS
`USP Reference Standards (added)
`Hydroxypropyl Corn Starch, 5372 (new)
`Hydroxypropyl Pea Starch, 5374 (new)
`Hydroxypropyl Potato Starch, 5376 (new)
`
`Alclometasone Dipropionate, 5378
`IMPURITIES
`Organic impurities
`ADDITIONAL REQUIREMENTS
`USP Reference Standards
`Amlodipine Besylate Tablets, 5379
`IMPURITIES
`Organic Impurities (subsection Analysis and Accep-
`tance criteria)
`ADDITIONAL REQUIREMENTS
`USP Reference Standards
`Ammonium Molybdate, 5380
`ASSAY
`Procedure (subsections Sample solution and
`Analysis)
`IMPURITIES
`Inorganic Im urities (subsection Arsenate, Phos-
`phate, and ilicate)
`Amoxicillin Capsules, 5381
`IDENTIFICATION
`ASSAY
`Procedure (subsections Mobile phase, Sample solu-
`tion, Chromatographic system, and System
`suitability)
`SPECIFIC TESTS
`_
`Water Determination (deleted)
`Microbial Enumeration Tests and Tests for Specified MI-
`croorganisms (added)
`Amoxicillin and Clavulanate Potassium for Oral Suspen-
`sion, 5382
`ASSAY
`Procedure (subsections Mobile phase and System
`suitability)
`__
`SPECIFIC TESTS
`Microbial Enumeration Tests and Tests for Specified
`Microorganisms (added)
`Amoxicillin and Clavulanate Potassium Tablets, 5383
`ASSAY
`Procedure (subsections Mobile phase, Sample stock
`solution, and System suitability)
`PERFORMANCE TESTS
`Uniformity of Dosage Units
`SPECIFIC TESTS
`_
`,
`Water Determination
`Microbial Enumeration Tests and Tests for Specified
`Microorganisms (added)
`Amoxicillin for Oral Suspension, 5384
`IDENTIFICATION
`ASSAY
`Procedure (subsections Mobile phase, Sample solu-
`tion, Chromatographic system, and System
`suitability)
`SPECIFIC TESTS
`,
`,
`Water Determination
`Microbial Enumeration Tests and Tests for Specified
`Microor anisms (added)
`Amoxicillin Ta lets, 5385
`IDENTIFICATION
`ASSAY
`Procedure (subsections Mobile phase, Sample solu-
`tion, Chromatographic system, and System
`suitability)
`,
`,
`SPECIFIC TESTS
`Microbial Enumeration Tests and Tests for Specified
`Microorganisms (added)
`Antihemophilic Factor, 5387 (deleted)
`Cryoprecipitated Antihemophilic Factor, 5387 (deleted)
`Antivenin (Crotalidae) Polyvalent, 5387 (deleted)
`Antivenin (Latrodectus mactans), 5387 (deleted)
`Antivenin (Micrurus fulvius), 5388 (deleted)
`
`Th is material WNa§I:>tJ'pIEr2I
`at the l‘eILhiI and may be
`Su i3jes:t L3 Cieipy right Laws
`
`

`
`5072 Annotated List
`
`Bicalutamide, 5388
`ASSAY
`
`Procedure (subsections Solution A, Solution B, Mobile
`phase, Diluent, System suitability solution, Standard
`solution, Sample solution, Chromatographic system,
`and System suitability)
`IMPURITIES
`Organic impurities
`ADDITIONAL REQUIREMENTS
`USP Reference Standards
`Anti-A Blood Grouping Serum, 5389 (deleted)
`Anti‘-B Blood Grouping Serum, 5389 (deleted)
`Blood Grouping Serums, 5390 (deleted)
`Blood Groupin Serums Anti-D, Anti-C, Anti-E, Anti-c,
`Anti-e, 5390 ( eleted)
`Whole Blood, 5391 (deleted)
`Botulism Antitoxin, 5393 (deleted)
`Bromocriptine Mesylate, 5394
`IMPURITIES
`
`Organic Impurities (subsection Procedure 2)
`Bupropion Hydrochloride Extended-Release Tablets, S395
`ASSAY
`
`Procedure (subsections Diluent 7, System suitability
`solution A, System suitability solution 3, Standard so-
`lution, Sample stock solution A, Sam le solution A,
`Buffer, Diluent 2, Sample stock solution B, Sample
`solution B, and Analysis
`IMPURITIES
`
`Organic Impurities (subsections Solution A, Solution
`B, Mobile phase, System suitability solution A, System
`suitability solution B, Standard solution, Sample solu-
`tion A or Sample solution B, and Chromatographic
`system, and Analysis)
`Carvedilol, 5399
`IMPURITIES
`
`Organic Impurities, Procedure 7 (subsection Accep-
`tance criteria)
`Carvedilol Tablets, 5401
`PERFORMANCE TESTS
`Dissolution (subsections Test
`Cefazolin Sodium, 5403
`IMPURITIES
`
`7 and Test 3)
`
`Organic impurities (subsection Acceptance criteria)
`Cefdinir, 5405
`SPECIFIC TESTS
`Water Determination
`Clonidine Transdermal System, 5407
`PERFORMANCE TESTS
`Drug Release (subsections Test I and Test 2)
`ADDITIONAL REQUIREMENTS
`Labeling
`Coccidioidin, 5410 (deleted)
`Codeine Sulfate, 5410
`DEFINITION
`ASSAY
`IMPURITIES
`
`Organic impurities (subsection Procedure I)
`Codeine Sulfate Tablets, 5411
`ASSAY
`PERFORMANCE TESTS
`Dissolution (subsections Apparatus 2, Cell, Blank,
`and Sample solution)
`IMPURITIES
`Organic Impurities (added)
`Diphtheria and Tetanus Toxoids Adsorbed, 5413
`(deleted)
`Divalproex Sodium, 5413
`SPECIFIC TESTS
`Water Determination
`Doxycycline Hyclate Delayed-Release Tablets, 5414
`SPECIFIC TESTS
`Water Determination (deleted)
`Escitalopram Tablets, 5414 (new)
`Ethynodiol Diacetate and Ethinyl Estradiol Tablets, 5417
`
`Second Supplement to ugp 34_NF 29
`IDENTIFICATION
`EtomidT2iht,:, IS?/leg fr/ié%mtogmph’° Identification Test
`Etomidate Injection, 5419 (new)
`Fentanyl, 5420
`ASSAY
`
`”v|l;l'LOJ§?_f"L*IEI‘S€ (subsection System suitability solution)
`Organic Impurities
`Fluticasone Propionate Nasal Spray, 5422
`OTHER COMPONENTS
`b:€0p,IE7eh7cteOcfri€¢:lI'f7)]lkOnlum Ch/Onde (Subsection Ac-
`Fluvastatin Sodium, 5425
`IDENTIFICATION
`
`solution, Sample
`
`t2’ ‘md Te“ 3)
`
`Identification Tests—General, Sodium
`IMPURITIES
`GanCiC('2)r\gicriIn§4l£n7purities (subsection Acceptance criteria)
`DEFINITION
`ASSAY
`Procedure (subsections Standard
`solution, and Acceptance criteria)
`Glimepiride Tablets, 5427
`PERFOR/MANCE EESTS
`Disso ution (su sections Test 7, Te:
`ADDITIONAL REQUIREMENTS
`Labeling (added)
`Anti-Human Globulin Serum, 5430 (deleted)
`Heparin Calcium, 5430 (deleted)
`Heparin Calcium Injection, 5432 (deleted)
`Histoplasmin, 5433 (deleted)
`Homatropine Methylbromide, 5433
`CHEMICAL INFORMATION
`DEFINITION
`IDENTIFICATION
`Test B (deleted)
`Test C (deleted)
`Test D (deleted)
`Identification Tests—General, Bromide
`ASSAY
`IMPURITIES
`Residue on Ignition
`Organic Impurities (added)
`SPECIFIC TESTS
`
`,
`PH
`Loss on Drying
`Homatro ine, Atropine, and Other Solanaceous Alka.
`loids (de eted)
`ADDITIONAL REQUIREMENTS
`Packaging and Storage
`USP Reference Standards
`Influenza Virus Vaccine, 5435 (deleted)
`Leuprolide Acetate, 5435
`ASSAY
`Procedure (subsection Analysis)
`OTHER COMPONENTS
`
`Content of Acetic Acid (subsection System suitability)
`IMPURITIES
`
`Chromatographic Purity (subsection Analysis)
`Levetiracetam, 5437
`ASSAY
`
`Procedure (subsection Suitability requirements)
`SPECIFIC TESTS
`Limit of Levetiracetam R-Enantiomer (subsection Mo-
`bile phase)
`Lidocaine, 5439
`IDENTIFICATION
`Test B
`IMPURITIES
`Chloride and Sulfate, Sulfate
`ADDITIONAL REQUIREMENTS
`Packaging and Storage
`
`This rnaterial waste-piEcI
`at the NLM and may be
`Subject IJS Copyright Laws
`
`

`
`Second Supplement to USP 34—NF 29
`
`Annotated List 507 3
`
`Lidocaine Hydrochloride, 5440
`IDENTIFICATION
`Test 8
`IMPURITIES
`Chloride and Sulfate, Sulfate
`ADDITIONAL REQUIREMENTS
`Packaging and Storage
`Loxapine Succinate, 5441
`CHEMICAL INFORMATION
`ASSAY
`Procedure (subsection Analysis)
`IMPURITIES
`Organic Impurities
`SPECIFIC TESTS
`Me/ting Range or Temperature (deleted)
`ADDITIONAL REQUIREMENTS
`USP Reference Standards
`Measles Virus Vaccine Live, 5442 (deleted)
`Measles, Mumps, And Rubella Virus Vaccine Live, 5442
`(deleted)
`Measles and Rubella Virus Vaccine Live, 5443 (deleted)
`Mefloquine Hydrochloride, 5443
`DEFINITION
`ASSAY
`Procedure (subsections System suitability and Accep-
`tance criteria)
`Methotrexate, 5444
`ASSAY
`Procedure (subsections Buffer, Solution A, Solution 8,
`Mobile phase, Standard stock solution, Standard
`solution, Sample stock solution, Sample solution,
`Chromatographic system, System suitability, and
`Analysis)
`IMPURITIES
`Inorganic impurities (subsection Heavy Metals)
`Organic Impurities
`SPECIFIC TESTS
`Optical Rotation, Specific Rotation (deleted)
`ADDITIONAL REQUIREMENTS
`USP Reference Standards
`Methylergonovine Maleate Injection, 5446
`ADDITIONAL REQUIREMENTS
`Packaging and Storage
`Mumps Skin Test Anti en, 5447 (deleted)
`Mumps Virus Vaccine
`ive, 5448 (deleted)
`Mycophenolate Mofetil Tablets, 5448
`PERFORMANCE TESTS
`Dissolution (subsection Test 7, Test 2, Test 3)
`IMPURITIES
`Limit of Degradation Products (subsection Accep-
`tance criteria)
`ADDITIONAL REQUIREMENTS
`Labeling (added)
`ggsthindrone Acetate and Ethinyl Estradiol Tablets,
`IDENTIFICATION
`ASSAY
`PERFORMANCE TESTS
`Uniformity of Dosage Units
`ADDITIONAL REQUIREMENTS
`Packaging and Storage
`Norgestimate and Ethinyl Estradiol Tablets, 5452
`IMPURITIES
`Organic impurities (subsection System suitability)
`Ondansetron Orally Disintegrating Tablets, 5453
`IMPURITIES
`Organic Impurities (subsection Acceptance criteria)
`gfycodone Hydrochloride Extended-Release Tablets,
`54
`IDENTIFICATION
`IMPURITIES
`Organic Impurities (added)
`ADDITIONAL REQUIREMENTS
`USP Reference Standards
`Phenoxybenzamine Hydrochloride Capsules, 5457
`
`7 and Test 2)
`
`PERFORMANCE TESTS
`Dissolution (subsections Standard solution, Sample
`solution, pH 3.0 phosphate buffer, Mobile phase,
`Chromatographic system, System suitability)
`Platelet Concentrate, 5458 (deleted)
`Poliovirus Vaccine inactivated, 5459 (deleted)
`Povidone, 5459
`DEFINITION
`IDENTIFICATION
`Test D (added)
`IMPURITIES
`Limit of Aldehydes (subsection Sample solution)
`Vinylpyrrolidinone (subsections Chromatographic sys-
`tem and System suitability)
`2-Pyrrolidone (added)
`Peroxides (added)
`Formic Acid (added)
`SPESIFIC TESTS
`Rabiespvaccine, 5462 (deleted)
`Risedronate Sodium, 5462
`ASSAY
`Procedure (subsection System suitability)
`IMPURITIES
`O anic Impurities, Procedure I (subsections System
`suitability, Analysis, and Acceptance criteria)
`SPECIFIC TESTS
`Water Determination, Method lc
`Rubella Virus Vaccine Live, 5464 (deleted)
`Smallpox Vaccine, 5465 (deleted)
`Sumatriptan Tablets, 5465
`IDENTIFICATION
`Infrared Absorption
`PERFORMANCE TESTS
`Dissolution (subsections Test
`ADDITIONAL REQUIREMENTS
`Labeling (added)
`Tamsulosin Hydrochloride Capsules, 5466
`IDENTIFICATION
`ASSAY
`Procedure 9 (added)
`PERFORMANCE TESTS
`Dissolution (subsection Test 9)
`ADDITIONAL REQUIREMENTS
`Labeling (added)
`Tetanus Toxoid, 5474 (deleted)
`Tetanus Toxoid Adsorbed, 5474 (deleted)
`Tetanus and Diphtheria Toxoids Adsorbed for Adult Use,
`5475 (deleted)
`Thrombin, 5475 (deleted)
`‘
`Trandolapril Tablets, 5475 (new)
`Triamcinolone Acetonide Injectable Suspension, 5477
`ASSAY
`V
`Procedure (subsection Chromatographic system)
`PERFORMANCE TESTS
`Uniformity of Dosage Units (added)
`ADDITIONAL REQUIREMENTS
`Packaging and Storage
`Triamcinolone Hexacetonide, 5477
`.
`,
`,
`,
`ASSAY
`Procedure (subsection System suitability solution)
`IMPURITIES
`_
`.
`.
`Organic impurities (subsection Procedure: Limit of
`Triamcinolone Acetonide)
`ADDITIONAL REQUIREMENTS
`Packaging and Storage
`_
`USP Reference Standards _
`Triamcinolone Hexacetonide Injectable Suspension, S478
`PERFORMANCE TESTS
`_
`Uniformity of Dosage Units (added)
`_
`,
`IMPURITIES
`‘
`Organic lrnpurities (subsection Procedure: Limit of
`Triamcinolone Acetonide)
`ADDITIONAL REQUIREMENTS
`Packaging and S lorage
`
`This rristie-rial was cs3:pie»:l
`at t.I'ie NLM ancl may tine
`Subject LIE {ks-pyright Law-5
`
`

`
`5074 Annotated List
`
`Second Supplement to USP 34—NF 29
`
`USP Reference Standards
`Trospium Chloride, 5479 (new)
`Tuberculin, 5481 (deleted)
`Valacyclovir Hydrochloride, 5481
`lMPURlTlES
`Heavy Metals, Method ll
`Organic Impurities, Procedure 2 (subsection Accep—
`tance criteria)
`
`_
`SPECIFIC TESTS_
`Water Determination
`Vasopressin, 5483
`DEFlNlTlON
`Vitamin A Tablets, 5484 (new)
`Yellow Fever Vaccine, 5486 (deleted)
`Zaleplon, 5486 (new)
`Zaleplon Capsules, 5487 (new)
`
`This material w‘ast~:»pied
`at the N LM and may be
`in Djiltt US {;{:'pyrig;ht: La W5
`
`

`
`Second Supplement to USP 34—NF 29
`
`Introduction 50 75
`
`c
`Second Supplement to
`USP .M—NF 29
`
`This section provides selected basic information about the
`Second Supplement to the 34”‘ revision of the United States
`Pharmacopeia (USP 34) and the 29"‘ edition of the National
`Formulary (NF 29). Please refer to USP 34—NF 29 for more
`general and complete information about this Supplement
`and the overall compendia of which it is a part. Text in the
`Second Supplement to USP 34—NF 29 is official December 1
`2011, unless otherwise noted.
`'
`
`MISSION STATEMENT
`
`USP—NF is published in continuing ursuit of the mission
`of USP: To improve the health of peop e around the world
`through public standards and related rograms that help en-
`sure the quality, safety, and benefit 0 medicines and foods.
`USP—NF Organization
`in-
`USP—NF is printed as a three-volume set. Volume I
`cludes front matter (Mission and Preface, People, Govern-
`ance pages and Web sites, and Admissions/Annotations). It
`also includes USP General Notices, general chapters, Dietary
`Supplement general chapters, Reagents, Reference Tables,
`Dietary Supp ement monographs, NF Admissions, Excipients,
`and NF monographs. Volume 2 includes USP monographs
`A—|, and Volume 3 includes USP monographs ]—Z. To facili-
`tate convenient use and reference, all three volumes include
`the full index. General chapters specific to dietary sup le-
`ments are included in numerical order with the rest oljthe
`general chapters in USP. Excipient monographs usually are
`presented in NF but also may appear in USP with suitable
`cross-referencing when they are also drug substances. The
`Excipients section (Volume 7) presents a tabulation of excipi-
`ents by functional category.
`Revisions to USP—NF
`
`USP—NF is continuously revised. Revisions are presented
`annually as Standard Revisions in USP-NF and in twice- early
`Supplements, and as Accelerated Revisions on USP’s We
`site
`(Errata, Interim Revision Announcements (IRAs), and Revision
`Bulletins).
`Standard Revisions——USP’s Standard Revision Process calls
`for publication of a proposed revision in the Pharmacopeial
`Forum (PF) for a 90-day notice and comment period and,
`after the revision is approved by the relevant USP Expert
`Committee, publication in the next USP—NF or Supplement,
`as applicable.
`Accelerated Revisions—The Accelerated Revision Process is
`used to make revisions to USP—NF official more quickly than
`through USP’s Standard Revision Process. Accelerated Revi-
`sions, which include Errata,
`IRAs, and Revision Bulletins, do
`not always require notice and comment and allow for a re-
`vision to become official prior to the next USP—NF or Supple-
`ment. See the USP Guideline on Use of Accelerated Processes
`for Revisions to the USP—NF, which is posted on USP’s Web
`site.
`
`Errata—Errata are considered to be text erroneously pub-
`lished in the USP—NF or Supplement that does not accurately
`
`reflect the intended requirements as approved by the Coun-
`cil of Experts. These typically are minor changes that are
`fairly obvious and do not have a broad impact. Errata are
`not subject to notice and comment. Errata are published on
`USP’s Web site and are immediately official. Errata are incor-
`porated into the next available USP—NF or Supplement.
`Interim Revision Announcements (lRAs)—IRAs are an expe-
`dited mechanism for making revisions official. An IRA ap-
`pears in PF first as a Proposed Interim Revision Announcement
`with a 90-day comment period [beginning with PF 37(1)]. if
`there are no si nificant comments, the IRA becomes official
`in the "New 0 ficial Text” section of USP’s Web site, with
`the official date indicated. IRAs are incorporated into the
`next available USP—NF or Supplement.
`Revision Bulletins——lf circumstances require rapid publica-
`tion of official text, a revision or postponement may be
`published through a Revision Bulletin. Revision Bulletins are
`posted on USP’s Web site with the official date indicated.
`Revision Bulletins are incorporated into the next available
`USP—NF or Supplement.
`Pharmaco eial Forum (PF)—The PF is USP’s official publi-
`cation for pu lic notice and comment. Proposals for revi-
`sion are presented in the In-Process Revisions or the Prgposed
`Interim Revision Announcement sections and represent
`raft
`revisions that are expected to advance to official status
`pending final review and approval by the relevant Expert
`Committee.
`_
`On January 3, 2011, PF transitioned to an online-only
`publication that is available free of charge. The print ver-
`sion is no longer available. The new online-onl
`PF includes
`proposed changes and additions to the USP— F, including
`Sta e 4 Harmonization, and Stimuli articles for which USP is
`see ing public comments. All proposals, including IRAs, will
`have a 90-day comment period. Other information currently
`contained in PF, including official text (final IRAs) has been
`moved into other USP publications or will be published
`__
`solely on USP’s Web site.
`This change to make PF freely available will better facili-
`tate open and public participation when revisions are pro-
`posed to the USP—NF.
`Su pIements——Supplements to USP—NF follow a standard
`scheclilile each year: The First Supplement is published in Feb-
`ruary and becomes official August 1. The Second Supplement
`is published in June and becomes official December 1. Users
`of USP print products must retain Sigmlements and check
`the ”New Official Text" section of U P's Web site in order to
`have up-to-date official text. The USP-NF online version is
`updated with each Supplement or annual revision. Each time
`a new edition or Supplement is released during the subscrip-
`tion period, a new CD is issued. The Index in each Sup le- _
`ment is cumulative and includes citations to the annua revi-
`sion and, for the Second Supplement, citations to the First
`Supplement. The contents of the two Supplements are inte-
`grated into the annual edition of the fo lowing year, alon
`with new official revisions that have been adopted since t e
`Second Supplement to the previous compendia.
`
`Th is rn-:-itia-rial nvasfiva-plead
`atthe NU»! anizl may ble-
`Sulziject US {as-pyright Laws
`
`

`
`5076 introduction
`
`Symbols Indicating Changes to Official Text
`Symbols identify the beginning and end of each revision.
`The following table summarizes the types of symbols and
`the associated subscripts used in USP publications:
`
`Revision_‘_l'_vpe
`Interim Revision
`Announcement
`Revision Bulletin
`Text deletion
`
`Adopted in
`Supplement
`Adopted in
`USP-NF
`
`Symbol
`.f|eW teXt.(|l!A1-Feb-2011)
`
`new texto (lllll Jan-2011)
`O(li|3 Hail-201 I)
`oriivx l—l cbv20l 1)
`'11 s (UWJ4)
`‘A(U5l’3-1)
`‘HEW textlis (usm;
`
`‘new textui,;,a;4,
`
`Subscript
`(IRA 1-Feb-2011)
`
`(RB 1-Jan-2011)
`(RB 1-Jan-2011)
`(lRA1—Feb-2011)
`1S (USP34)
`USP 34
`15 or 2S (USP
`annual edition)
`USP annual edition
`
`In all revisions, the closing symbol is accompanied by a
`subscript number or date. For Revision Bulletins and IRAs, the
`closin
`symbol is accompanied b a subscript date indicat-
`ing w en the revision became 0 icial.
`For Supplements, the
`closing symbol is accom anied b
`y a subscript number indi-
`evision became official.
`cating the edition in which the r
`Interim Revision Announcements are shown with new text
`(if any) enclosed in circles, ‘new t€Xto(mA|.;e1;.2o|1). New text
`revised in Revision Bulletins is enclosed in circles, ‘new text.
`(RB1-|ari-2011)- Text enclosed in squares, ‘new teXtltS(USP34), al-
`ready has been adopted in a Supplement. Text that has been
`adopted in USP—NF is enclosed in triang18S, Anew 1Z€Xt‘(u5p34).
`Where the symbols appear together with no enclosed text,
`such as
`O(RB 1-Jan-201 1);
`O(lRAi-Feb-2011)r Or '
`l1S(USF34),
`it mC‘anS
`that text has been deleted and no new
`text has been pro-
`posed to replace it.
`
`IRAS and Supplements to USP 34—NF 29
` ,_j
`Official Dates and Symbols
`Proposed
`IRA
`37(1)
`
`Official Date
`July 1, 2011
`Aug. 1, 2011
`Sept. 1, 2011
`Nov. 1, 2011
`Dec.