General Tests and Assays - USP-NF

1 7986 Annotated ListFirst Supplement to USP 40 NF 35 ANNOTATED LISTM onographs, General Chapters, Reagents, and Tables Affected by ChangesAppearing in This SupplementPage citations refer to the pages of this Supplement. Note In the lists below, if a section is new or if a subsection is added to ordeleted from an existing section, it is labeled as such in parentheses after the section or subsection name. Items on this list thatappear without the designation new , added , or deleted are items in which changes have been made to existing official Acid, n-Hydrate, 8126 General ChaptersSodium 1-Hexanesulfonate Monohydrate, 8126 Sulfaguanidine (new), 8126 Tosylchloramide Sodium (new), 8126 Tyrosol (new), 8126 General Tests and AssaysXylometazoline Hydrochloride (new), 8126 Test SolutionsBiological Tests and M Phosphoric Acid TS (new), 8127 126 Somatropin Bioidentity Tests , 8057 Volumetric N Hydrochloric Acid VS, 8127 Chemical Tests and N Sulfuric Acid VS (new), 8127 210 Monosaccharide Analysis (new), 8059 Chromatographic Columns 232 Elemental Impurities Limits, 8065L91, 8127 Introduction, Routes of Exposure, Drug Products,L99 (new), 8127 Drug Substance and Excipients, and AnalyticalL105 (new), 8127 Testing 371 Cobalamin Radiotracer Assay (deleted)

2 ,8069 Reference TablesPhysical Tests and Determinations 621 Chromatography, 8071 Container Specifications for Capsules and TabletsChromatographic Columns and SystemAcetohexamide Tablets (deleted), 8129 SuitabilityEchinacea Species Dry Extract Capsules (new),8132 Echinacea Species Dry Extract Tablets (new), 8132 General InformationOlmesartan Medoxomil Tablets (new), 8135 Paricalcitol Capsules (new), 8136 1058 Analytical Instrument Qualification, 8083 Ramipril Tablets (new), 8136 1171 Phase-Solubility Analysis (deleted), 8090 Description and Relative Solubility of USP and NF 1225 Validation of Compendial Procedures,Articles8094 Acetohexamide (deleted), 8139 ValidationCeftiofur Hydrochloride (new), 8149 1790 Visual Inspection of Injections (new), 8099 Ceftiofur Sodium (new), 8149 cetylpyridinium chloride , 8150 Reagents, Indicators, andCidofovir (new), 8152 Dalfampridine (new), 8154 SolutionsDesogestrel (new), 8155 Desoxycholic Acid, 8155 Reagent SpecificationsEsomeprazole Strontium (new), 8159 Acetaldehyde Ammonia Trimer Trihydrate (new),Nilutamide (new), 81758124 Pregabalin (new), 8184 Bacterial Alkaline Protease Preparation, 8124(S)-Binol (new), 8124 Monographs (USP 40)2,6-Diaminopyridine (new), 81242,6-Dichloroquinone-chlorimide, 8124 Ether, Peroxide-Free, 8124 Acetaminophen and Codeine Phosphate Cap-Ethylparaben (new), 8124sules, 8201 Filter Paper, Quantitative (deleted), 8124 ASSAYG uaifenesin (new), 8124 Procedure5-Hydroxymethylfurfural (new), 8124 PERFORMANCE TESTSL actic Acid (new), 8124 Dissolution and Uniformity of Dosage UnitsMarfey s Reagent (new), 8124 IMPURITIESL-Methionine Sulfoxide (new), 81244-Aminophenol in Acetaminophen-Containing1-Methylimidazol e (new), 8124 Drug Products (added)2-Methylimidazole (new), 8124 Acetaminophen and Codeine Phosphate Tablets,Montelukast Sodium Hydrate (new)

3 , 812482021-Naphthol, 8125 DEFINITIONP epsin, 8125 ASSAYP ropylparaben (new), 8126 ProcedureResorcinol (new), 8126 First Supplement to USP 40 NF 35 Annotated List7987 PERFORMANCE TESTSASSAYD issolution and Uniformity of Dosage UnitsProcedureIMPURITIESIMPURITIES4-Amin ophenol in Acetaminophen-ContainingOrganic Impurities (added)Drug Products (added)ADDITIONAL REQUIREMENTSA cetohexamide (deleted), 8204 USP Reference StandardsAcetohexamide Tablets (deleted), 8204 Buprenorphine Hydrochloride, 8218 Aloe, 8205 DEFINITIONCONTAMINANTSIDENTIFICATIONA rticles of Botanical Origin, Pesticide ResidueTest B and Identification Tests General ,Analysis (added)Chemical Identification Tests , chloride , Test CAminohippurate Sodium Injection, 8206 ASSAYIDENTIFICATIONP rocedureTest CIMPURITIESA spartic Acid, 8206 Organic ImpuritiesIMPURITIESSPECIFIC TESTSR elated CompoundspH (deleted) and Acidity or AlkalinityAtropine Sulfate Ophthalmic Ointment, 8207(added)SPECIFIC TESTSADDITIONAL REQUIREMENTSO ther RequirementsUSP Reference StandardsBacitracin Ophthalmic Ointment, 8208 Bupropion Hydrochloride Extended-Release Tab-SPECIFIC Tests lets, 8219 Other RequirementsIDENTIFICATIONB acitracin Zinc and Polymyxin B SulfateTest BOphthalmic Ointment, 8209 ASSAYSPECIFIC TESTSP rocedureOther RequirementsPERFORMANCE TESTSB elladonna Leaf, 8209 DissolutionCONTAMINANTSIMPURITIESA rticles of Botanical Origin, Pesticide ResidueOrganic ImpuritiesAnalysis (added)Butamben, 8228 Benzocaine, Butamben, and Tetracaine Hydro-DEFINITION chloride Topical Aerosol, 8211 IDENTIFICATIONIDENTIFICATIONTest A and Test B (added)Test B (added)ASSAYASSAYP rocedureProcedureIMPURITIESPERFORMANCE TESTSC hloride (deleted) and Organic ImpuritiesMinimum Fill (added)(added)IMPURITIESSPECIFIC TESTSO rganic Impurities (added)Completeness and Color of Solution (de-SPECIFIC Tests leted).

4 Melting Range or Temperature, Class IInhalation and Nasal Drug Products: Aero-(deleted); and Reaction (deleted)sols, Sprays, and Powders PerformanceADDITIONAL REQUIREMENTSQ uality Tests (deleted), Topical AerosolsUSP Reference Standards(added), and Leak Rate (added)Cabergoline Tablets, 8229 ADDITIONAL REQUIREMENTSIDENTIFICATIONUSP Reference StandardsTest A and Test B (added)Benzocaine, Butamben, and Tetracaine Hydro-ASSAY chloride Gel, 8213 ProcedureIDENTIFICATIONPERFORMANCE TESTSTest B (added)DissolutionASSAYIMPURITIESP rocedureOrganic ImpuritiesIMPURITIESC arisoprodol Tablets, 8230 Organic Impurities (added)IDENTIFICATIONSPECIFIC TESTSTest B (added)Microbial Enumeration Tests (added) andPERFORMANCE TESTST ests for Specified Microorganisms (added)DissolutionADDITIONAL REQUIREMENTSIMPURITIESP ackaging and Storage and USP ReferenceOrganic ImpuritiesStandardsCeftiofur Hydrochloride (new), 8232 Benzocaine, Butamben, and Tetracaine Hydro-Ceftiofur Sodium (new)

5 , 8234chloride Topical Solution, 8214 Cefuroxime Axetil, 8237 IDENTIFICATIONIDENTIFICATIONTest B (added)Test B (added)ASSAYASSAYP rocedureProcedureIMPURITIESIMPURITIESO rganic Impurities (added)Organic Impurities (added)ADDITIONAL REQUIREMENTSSPECIFIC TESTSUSP Reference StandardsDiastereoisomer RatioBetamethasone Valerate Lotion, 8216 ADDITIONAL REQUIREMENTSIDENTIFICATIONUSP Reference StandardsTest A and Test B (added)7988 Annotated ListFirst Supplement to USP 40 NF 35 Cefuroxime Axetil Tablets, 8238 IMPURITIESIDENTIFICATIONL imit of Lead and Organic Impurities (added)Test ASPECIFIC TESTSASSAYO ptical Rotation, Procedures, Specific Rota-Proceduretion; Melting Range or Temperature (de-PERFORMANCE Tests leted); Loss on Drying (deleted); Water De-Dissolutiontermination, Method I, Method Ic (added);IMPURITIESC larity of Solution (added); Color of SolutionOrganic Impurities (added)(added); Bacterial Endotoxins Test (added);SPECIFIC TESTSM icrobial Enumeration Tests (added).

6 AndWater Determination, Method I (deleted) Tests for Specified Microorganisms (added)ADDITIONAL REQUIREMENTSADDITIONAL REQUIREMENTSP ackaging and Storage and USP ReferenceLabeling (added) and USP Reference Stan-Standardsdards (added)Chloramphenicol Ophthalmic Ointment, 8241 Dexamethasone Topical Aerosol (deleted), 8262 SPECIFIC TESTSD examethasone Gel (deleted), 8263 Other RequirementsDexamethasone Sodium Phosphate OphthalmicChloramphenicol and Polymyxin B SulfateOintment, 8263 Ophthalmic Ointment, 8241 SPECIFIC TESTSSPECIFIC Tests Other RequirementsOther RequirementsDicloxacillin Sodium, 8264 Chlortetracycline Hydrochloride Ophthalmic Oint-CHEMICAL INFORMATION ment, 8242 IMPURITIESSPECIFIC Tests Organic ImpuritiesOther RequirementsDigitalis, 8266 Ciprofloxacin Ophthalmic Ointment, 8242 ASSAYSPECIFIC TESTSP rocedureOther RequirementsCONTAMINANTSC iprofloxacin for Oral Suspension (new), 8243 Articles of Botanical Origin, Pesticide ResidueCiprofloxacin Tablets, 8245 Analysis (added)IDENTIFICATIOND ivalproex Sodium Delayed-Release Capsules,Test B (added)8267 ASSAYPERFORMANCE TESTSP rocedure DissolutionIMPURITIESD ocetaxel, 8270 Organic Impurities (added)IDENTIFICATIONADDITIONAL REQUIREMENTS Infrared Absorption, Test APackaging and StorageASSAYC lavulanate Potassium, 8246 ProcedureASSAYIMPURITIESP rocedure Organic Impurities, Procedure 1 IMPURITIESADDITIONAL REQUIREMENTSP rocedure 1, Procedure 2: Limit of Clavam-Packaging and Storage2-carboxylate Potassium, and Procedure 3.

7 Doxycycline for Injection, 8273 Limit of Aliphatic AminesIDENTIFICATIONC yproheptadine Hydrochloride, 8249 Test A and Test B (added)DEFINITIONASSAYIDENTIFICATIONP rocedure Test B and Test C (deleted)IMPURITIESASSAYO rganic Impurities (added)ProcedureSPECIFIC TESTSIMPURITIESS terility Tests Organic ImpuritiesADDITIONAL REQUIREMENTSSPECIFIC TESTSUSP Reference Standards Acidity (deleted)Doxycycline Tablets, 8275 Dalfampridine (new), 8250 IDENTIFICATIOND esogestrel (new), 8252 Test B (added)Desoximetasone Cream, 8254 ASSAYIDENTIFICATIONP rocedureTest AIMPURITIESD esoximetasone Gel, 8255 Organic ImpuritiesIDENTIFICATIONADDITIONAL REQUIREMENTSTest AUSP Reference StandardsASSAYE rythromycin Ophthalmic Ointment, 8276 ProcedureSPECIFIC TESTSD esoximetasone Ointment, 8256 Other RequirementsIDENTIFICATIONE smolol Hydrochloride, 8278 Test ASPECIFIC TESTSD esoxycholic Acid, 8259pHTITLEADDITIONAL REQUIREMENTSDEFINITIONUSP Reference StandardsIDENTIFICATIONE someprazole Magnesium Delayed-Release Cap-Test A and Test B (added)sules, 8279 ASSAYPERFORMANCE TESTSP rocedureDissolutionFirst Supplement to USP 40 NF 35 Annotated List7989 ADDITIONAL REQUIREMENTSADDITIONAL REQUIREMENTSL abeling (added)Packaging and Storage and USP ReferenceEthambutol Hydrochloride Compounded OralStandardsSuspension (new)

8 , 8282 Idarubicin Hydrochloride Injection, 8301 Etidronate Disodium, 8283 ASSAYIDENTIFICATIONP rocedureInfrared Absorption, Test A and Test CIdoxuridine Ophthalmic Ointment, 8302(added)SPECIFIC TESTSASSAYO ther RequirementsProcedureImipramine Hydrochloride Tablets, 8303 ADDITIONAL REQUIREMENTSIDENTIFICATIONUSP Reference StandardsTest A and Test B (added)Etidronate Disodium Tablets, 8284 ASSAYIDENTIFICATIONP rocedureInfrared Absorption, Test A and Test BPERFORMANCE Tests (added)Dissolution and Uniformity of Dosage UnitsASSAYIMPURITIESP rocedureOrganic Impurities (added)PERFORMANCE TESTSADDITIONAL REQUIREMENTSD issolutionPackaging and Storage and USP ReferenceIMPURITIESS tandardsLimit of Phosphite and Phosphate (added)Indomethacin for Injection, 8305 ADDITIONAL REQUIREMENTSIDENTIFICATIONUSP Reference StandardsTest BEtomidate, 8286 ASSAYASSAYP rocedureProcedureIMPURITIESIMPURITIESC ontent of Indomethacin Related CompoundOrganic ImpuritiesBSPECIFIC TESTSADDITIONAL REQUIREMENTSLoss on DryingPackaging and Storage and USP ReferenceEtomidate Injection, 8287 StandardsASSAYI ndomethacin Oral Suspension, 8306 ProcedureIDENTIFICATIONIMPURITIESTest A and Test BOrganic Impurities, Procedure 1: RelatedASSAYC ompounds and Organic Impurities, Proce-Proceduredure 2.

9 Total Propylene Glycol EstersOTHER COMPONENTSE zetimibe Tablets, 8289 Content of Sorbic Acid (if present) (deleted)PERFORMANCE TESTSIMPURITIESD issolutionContent of Indomethacin Related CompoundIMPURITIESBO rganic ImpuritiesADDITIONAL REQUIREMENTSF lumazenil Injection, 8290 Packaging and Storage and USP ReferenceIDENTIFICATIONS tandardsTests B (added)Indomethacin Sodium, 8308 ASSAYDEFINITIONP rocedureIDENTIFICATIONADDITIONAL REQUIREMENTSTest A, Test B, and Test C (added)USP Reference StandardsASSAYF luticasone Propionate Lotion (new), 8291 ProcedureGentamicin and Prednisolone Acetate OphthalmicIMPURITIESO intment, 8293 Organic ImpuritiesSPECIFIC TESTSADDITIONAL REQUIREMENTSO ther RequirementsUSP Reference StandardsGentamicin Sulfate Ophthalmic Ointment, 8294 Insulin Glargine, 8310 SPECIFIC TESTSDEFINITIONO ther RequirementsIDENTIFICATIONG luconolactone, 8294 Peptide Mapping, Test BIDENTIFICATIONASSAYTest AProcedureADDITIONAL REQUIREMENTSPRODUCT-RELATED SUBSTANCES ANDUSP Reference Standards (added)IMPURITIESG oserelin Implants (new), 8295 Product-Related SubstancesHydrocortisone Acetate Ophthalmic Ointment,SPECIFIC TESTS8299 Water Determination, Method Ic and Loss onSPECIFIC TESTSD rying (added)Other RequirementsADDITIONAL REQUIREMENTSH ydroxyzine Hydrochloride Oral Solution, 8299 LabelingIDENTIFICATIONI nsulin Glargine Injection, 8312 Test A and Test B (added)ASSAYASSAYP rocedureProcedureOTHER COMPONENTSIMPURITIESZinc DeterminationOrganic Impurities (added)

10 7990 Annotated ListFirst Supplement to USP 40 NF 35 PRODUCT-RELATED SUBSTANCES ANDADDITIONAL REQUIREMENTSIMPURITIESP ackaging and Storage and USP ReferenceProduct-Related Substances and Limit of HighStandardsMolecular Weight ProteinsMethionine, 8337 Ipecac, 8314 IMPURITIESCOMPOSITIONR elated CompoundsEmetine and CephaelineADDITIONAL REQUIREMENTSCONTAMINANTSUSP Reference StandardsArticles of Botanical Origin, Pesticide ResidueMethyldopa, 8339 Analysis (added)DEFINITIONIron Sucrose Injection, 8316 IDENTIFICATIONASSAYI nfrared Absorption, Test A, Test B, and TestIronC (deleted)ADDITIONAL REQUIREMENTSASSAYL abelingProcedureIsoleucine, 8318 IMPURITIESIMPURITIESL imit of 3-O-Methylmethyldopa (deleted)Related Compoundsand Organic Impurities (added)ADDITIONAL REQUIREMENTSADDITIONAL REQUIREMENTSUSP Reference StandardsUSP Reference StandardsLeucine, 8319 Methylene Blue Injection, 8341 IMPURITIESDEFINITIONR elated CompoundsIDENTIFICATIONADDITIONAL REQUIREMENTSTest A and Test BUSP Reference StandardsASSAYL euprolide Acetate, 8320 ProcedureIDENTIFICATIONIMPURITIESTest A and Test BOrganic Impurities (added) and Limit of Az-ASSAYure B (added)ProcedureADDITIONAL REQUIREMENTSOTHER COMPONENTSP ackaging and Storage and USP ReferenceAcetic Acid Content (deleted) and Acetic AcidStandardsin Peptides (added)Methylphenidate Hydrochloride Extended-ReleasePRODUCT-RELATED SUBSTANCES ANDT ablets, 8343 IMPURITIESPERFORMANCE TESTSL euprolide-Related ImpuritiesDissolutionPROCESS-RELATED IMPURITIESIMPURITIEST rifluoroacetic Acid (TFA) in Peptides (added)Organic ImpuritiesSPECIFIC TESTSADDITIONAL REQUIREMENTSA cetic Acid Content (deleted), Residue on Ig-USP Reference Standardsnition (deleted)