General Tests and Assays - USP-NF

1 XxxviAnnotated ListUSP 41 ANNOTATED LISTG eneral Notices, Monographs, General Chapters, Reagents, and TablesAffected by Changes Appearing in USP 41 Page citations refer to the pages of USP 41. Note In the table 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 Sodium Salt, MonohydrateGeneral Notices(new), 5712 Paired Ion Chromatography Reagent (new), 5713 General Notices, 3 Pancreatic Digest of Casein, 57133. Conformance to Standards; 5. Monograph9Z-Retinoic Acid, 5724 Components; 6. Testing Practices andSodium Pentacyanoammineferrate(II), 5731 ProceduresIndicatorsIndicators Introduction, 57451.

2 ScopeGeneral ChaptersIndicator and Test PapersIndicator and Test Papers Introduction, 5747 Buffer SolutionsGeneral Tests and AssaysBuffer Solutions Introduction, 57483. UsesChemical Tests and AssaysColorimetric Solutions 227 4-Aminophenol in Acetaminophen-Contain-Colorimetric Solutions Introduction, 5749ing Drug Products, 61411. Definition and 3. Comparison of ColorsSolution Preparations and USP Reference Stan-Test Solutionsdards (added)Test Solutions Introduction, 5750 591 Zinc Determination, 63251. Use as IndicatorsINTRODUCTION5 N Hydrochloric Acid TS (new), M Phosphoric Acid TS (new), 5757 Ion Chromatographic Method (added) Phosphoric Acid TS (new), 5758 ADDITIONAL REQUIREMENTS (added)10M Potassium Hydroxide TS (new), 5758 Physical Tests and M Sodium Chloride TS (new), 5759 659 Packaging and Storage Requirements, 6384 Volumetric SolutionsIntroduction and PackagingVolumetric Solutions Introduction, 5761 661 Plastic Packaging Systems and Their N Potassium Hydroxide VS (new), 5769als of Construction, N Sodium Hydroxide VS (new), 5770 Plastic Materials of Construction, N Sodium Hydroxide VS (new), 5770 Plastic Packaging Systems for M Sodium Thiosulfate VS (new), 5772tical Use, 6424 Chromatographic ColumnsIntroduction (added), Scope, Test methods ,L52, 5775 Specifications and Functionality (added)L100 (new)

3 , 5777 671 Containers Performance Testing, 6436L102, (new), 5777L103 (new), 5777 General InformationL108 (new), 5777L109 (new), 5777 1052 Biotechnology-Derived Articles AminoAcid Analysis, 6961 Reference TablesProtein Hydrolysis Storage and Transportation of Investiga-Container Specifications for Capsules and Tabletstional Drug Products (new), 7130 Atorvastatin Calcium Tablets (new), 5782 1210 Statistical Tools for Procedure ValidationBetamethasone Tablets (deleted), 5782(new), 7622 Buprenorphine and Naloxone Sublingual Tablets 1211 Sterility Assurance, 7633(new), 5782 Carbidopa and Levodopa Tablets, 5782 Reagents, Indicators, andCefaclor Tablets, Chewable (deleted), 5783 Echinacea Species Powder Capsules (new), 5784 SolutionsTelmisartan and Amlodipine Tablets (new), 5789 Temozolomide Capsules (new), 5789 Reagent SpecificationsTrandolapril and Verapamil Hydrochloride Tablets,Aluminum Chloride (new), 5667 Extended-Release (new), 5790 Bromelain, 5676 Description and Relative Solubility of USP and NFDipicolinic Acid (new), 5693 ArticlesGelatin (new), 5697 Dronedarone Hydrochloride (new), 5809 Granisetron (new), 5815 Front MatterUSP 41 Annotated ListxxxviiMethylnaltrexone Bromide (new), 5825 Cefaclor, 741 Prasugrel Hydrochloride (new), 5835 CHEMICAL INFORMATIONR altegravir Potassium (new), 5838 ASSAYIMPURITIESADDITIONAL REQUIREMENTSM onographs (USP 41)USP Reference StandardsCefaclor Capsules, 743 Acetazolamide for Injection, 66 IDENTIFICATIONASSAYTest B (added)IMPURITIES (added)ASSAYADDITIONAL REQUIREMENTSPERFORMANCE TESTSP ackaging and Storage and USP ReferenceDissolutionStandardsIMPURITIESA lmotriptan Malate, 124 SPECIFIC Tests (deleted)

4 ASSAYADDITIONAL REQUIREMENTSIMPURITIESUSP Reference StandardsLimit of Almotriptan Related Compound DCefaclor for Oral Suspension, 744and Almotriptan N-Dimer, Organic ImpuritiesIDENTIFICATIONand Limit of Fumaric AcidTest B (added)SPECIFIC TESTSASSAYADDITIONAL REQUIREMENTSIMPURITIESUSP Reference StandardsSPECIFIC TESTSA mikacin, 201 Water Determination, Method I (deleted)IDENTIFICATIONADDITIONAL REQUIREMENTSI nfrared Absorption, Test AUSP Reference StandardsASSAYC efaclor Chewable Tablets (deleted), 746 Amikacin Sulfate, 202 Cefaclor Extended-Release Tablets, 746 IDENTIFICATIONIDENTIFICATIONI nfrared Absorption, Test ATest B (added)ASSAYASSAYA mikacin Sulfate Injection, 203 PERFORMANCE TESTSASSAYD issolutionAminobenzoate Sodium, 213 IMPURITIESCHEMICAL INFORMATION (added)SPECIFIC Tests (deleted)DEFINITIONADDITIONAL REQUIREMENTSIDENTIFICATIONUSP Reference StandardsTest A and Test BClindamycin Phosphate, 996 ASSAYASSAYIMPURITIESIMPURITIESADDITIONAL REQUIREMENTSADDITIONAL REQUIREMENTSUSP Reference StandardsUSP Reference StandardsAminobenzoic Acid Topical Solution (deleted),Clomipramine Hydrochloride Compounded Oral217 Suspension, Veterinary (new), 1017 Amoxicillin Capsules, 276 Cyanocobalamin Co 57 Capsules (deleted), 1055 ASSAYC yanocobalamin Co 57 Oral Solution (deleted),IMPURITIES (added)1056 ADDITIONAL REQUIREMENTSC yanocobalamin Co 58 Capsules (deleted), 1056 USP Reference StandardsCyproheptadine Hydrochloride Oral Solution,Amoxicillin Tablets, 2801136 ASSAYIDENTIFICATIONPERFORMANCE TESTSASSAYIMPURITIES (added)IMPURITIES (added)

5 ADDITIONAL REQUIREMENTSADDITIONAL REQUIREMENTSUSP Reference StandardsDexamethasone Sodium Phosphate CompoundedAtorvastatin Calcium Tablets (new), 395 Injection (new), 1205 BCG Live (deleted), 454 Dexmedetomidine Injection (new), 1215 Betamethasone Tablets (deleted), 504 Divalproex Sodium Delayed-Release Tablets, 1357 Buprenorphine and Naloxone Sublingual TabletsIDENTIFICATION(new), 571 Test B (added)Bupropion Hydrochloride Extended-Release Tab-ASSAY lets, 576 PERFORMANCE TESTSASSAYD issolutionPERFORMANCE TESTSD oxycycline Capsules, 1416 DissolutionPERFORMANCE TESTSIMPURITIESD issolutionCarbidopa and Levodopa Tablets, 693 ADDITIONAL REQUIREMENTSIDENTIFICATIONL abeling (added)Test ADoxycycline Hyclate Capsules, 1429 ASSAYIMPURITIESPERFORMANCE TESTSD oxycycline Hyclate Tablets, 1432 DissolutionIMPURITIESIMPURITIES (added)Doxycycline for Oral Suspension, 1421 ADDITIONAL REQUIREMENTSIDENTIFICATIONP ackaging and Storage and USP ReferenceASSAYS tandardsPERFORMANCE TESTSF ront MatterxxxviiiAnnotated ListUSP 41 dissolution (added)Levetiracetam Extended-Release Tablets, 2377 IMPURITIES (added)PERFORMANCE TESTSSPECIFIC TESTSD issolutionWater Determination, Method I (deleted)Lorazepam Injection, 2471 ADDITIONAL REQUIREMENTSIDENTIFICATIONE poetin (new), 1540 Test BFluticasone Propionate Nasal Spray, 1842 ASSAYIDENTIFICATIONIMPURITIESI nfrared Absorption, Test AADDITIONAL REQUIREMENTSASSAYM efenamic Acid, 2549 OTHER COMPONENTSIDENTIFICATIONC ontent of Benzalkonium ChlorideInfrared Absorption, Test APERFORMANCE TESTSASSAYIMPURITIESIMPURITIESSPECIFIC TESTSO rganic ImpuritiesDroplet Size Distribution (deleted) and SprayMenthol, 2572 Pattern (deleted)

6 ASSAYADDITIONAL REQUIREMENTSIMPURITIESUSP Reference StandardsRelated CompoundsGlimepiride, 1945 Methylphenidate Hydrochloride Extended-ReleaseIDENTIFICATIONT ablets, 2683 ASSAYASSAYIMPURITIESPERFORMANCE TESTSL imit of cis-Isomer (Glimepiride Related Com-Dissolutionpound A)IMPURITIESADDITIONAL REQUIREMENTSM etoprolol Succinate Extended-Release Tablets,USP Reference Standards2709 Glimepiride Tablets, 1947 IDENTIFICATIONIDENTIFICATIONTest C (added)Test B (added)ASSAYASSAYPERFORMANCE TESTSPERFORMANCE TESTSIMPURITIES (added)DissolutionADDITIONAL REQUIREMENTSIMPURITIESUSP Reference StandardsADDITIONAL REQUIREMENTSM ilrinone Lactate Injection (new), 2748 USP Reference StandardsMorphine Sulfate Compounded Injection (new),Granisetron (new), 19892813 Hydroxyzine Pamoate, 2095 Moxifloxacin Ophthalmic Solution, 2819 IDENTIFICATIONIDENTIFICATIONASSAYTest B (added)IMPURITIESASSAYO rganic Impurities (added)IMPURITIESADDITIONAL REQUIREMENTSSPECIFIC TESTSUSP Reference StandardspH and Osmolality and OsmolarityHydroxyzine Pamoate Capsules, 2097 Mycophenolic Acid Delayed-Release Tablets, 2838 IDENTIFICATIONASSAYASSAYPERFORMANCE TESTSPERFORMANCE TESTSD issolutionDissolutionIMPURITIESIMPURITIE S (added)ADDITIONAL REQUIREMENTSADDITIONAL REQUIREMENTSUSP Reference StandardsIndomethacin Capsules, 2151 Nicotine Polacrilex, 2932 IDENTIFICATIONDEFINITIONTest BASSAYASSAYSPECIFIC TESTSPERFORMANCE TESTSW ater Determination, Method I and Loss onUniformity of Dosage UnitsDryingIMPURITIES (added)Nilutamide (new), 2944 ADDITIONAL REQUIREMENTSP araldehyde, 3165 USP Reference StandardsDEFINITION (added)Ipratropium Bromide and Albuterol Sulfate Inhala-IDENTIFICATION tion Solution (new), 2228 ASSAY (added)

7 Diluted Isosorbide Dinitrate, 2267 IMPURITIESIDENTIFICATIONC hloride (deleted), Sulfate (deleted), Limit ofASSAYA cetaldehyde (deleted), and Organic Impuri-IMPURITIES ties (added)Itraconazole, 2290 SPECIFIC TESTSDEFINITIONC ongealing Temperature (deleted)IDENTIFICATIONADDITIONAL REQUIREMENTSTest B (added)USP Reference Standards (added)ASSAYP entazocine Injection, 3225 IMPURITIESIDENTIFICATIONO rganic ImpuritiesASSAYSPECIFIC TESTSIMPURITIES (added)Optical RotationADDITIONAL REQUIREMENTSF ront MatterUSP 41 Annotated ListxxxixPotassium Citrate Extended-Release Tablets, 3372 Test B (added)PERFORMANCE TESTSASSAYD issolutionPERFORMANCE TESTSP otassium Phosphates Compounded InjectionDissolution(new), 3387 IMPURITIESP romethazine Hydrochloride Injection, 3465 ADDITIONAL REQUIREMENTSIMPURITIESP ackaging and StorageRaltegravir Potassium (new), 3571 Warfarin Sodium, 4340 Selamectin, 3733 CHEMICAL INFORMATIONIMPURITIESIDENTIFICATIONO rganic ImpuritiesTest CSibutramine Hydrochloride (deleted), 3754 IMPURITIESS imvastatin Tablets, 3764 SPECIFIC TESTSIMPURITIESI sopropyl Alcohol Content (crystalline clath-Sodium Bicarbonate Compounded Injectionrate form)(new), 3778 ADDITIONAL REQUIREMENTSS odium Phosphates Compounded InjectionUSP Reference Standards(new), 3806 Zinc Oxide, 4381 Sulindac Tablets, 3889 DEFINITIONASSAYIDENTIFICATIONPERFORMANCE TESTSTest BUniformity of Dosage UnitsASSAYT acrine Capsules (deleted), 3905 SPECIFIC TESTST acrine Hydrochloride (deleted), 3906 AlkalinityTelmisartan and Amlodipine Tablets (new), 3960 ADDITIONAL REQUIREMENTST emozolomide Capsules (new), 3968 Zinc Oxide Neutral, 4382 Temozolomide for Injection (new)

8 , 3971 IDENTIFICATIONT opiramate, 4139 Test BASSAYASSAYIMPURITIESIMPURITIESL imit of Sulfamate and Sulfate; Organic Im-Mercury and Magnesium Oxidepurities, Procedure 1; Organic Impurities, Pro-ADDITIONAL REQUIREMENTS cedure 2; and Organic Impurities, ProcedurePackaging and Storage3 Zinc Oxide Powder (new), 4384 Trandolapril Tablets, 4161 Zinc Sulfate Ophthalmic Solution, 4387 IDENTIFICATIONIDENTIFICATIONTest B (added)ASSAYASSAYSPECIFIC TESTSIMPURITIESO ther Requirements (added)Trandolapril and Verapamil Hydrochloride Ex-Zolmitriptan Nasal Spray (new), 4397tended-Release Tablets (new), 4163 Triacetin, 4183 Monographs (DietaryDEFINITIONIDENTIFICATIONS upplements)Test BASSAYE chinacea Species Powder Capsules (new), 4595 IMPURITIES (added)Conjugated Linoleic Acids Free Fatty Acids (new),SPECIFIC TESTS4739 Specific Gravity (deleted), Refractive IndexTangerine Peel (new), 4894(deleted) and Acidity (deleted)Tangerine Peel Dry Extract (new), 4896 Verapamil Hydrochloride Extended-Release Cap-Tangerine Peel Powder (new), 4898sules, 4302 IDENTIFICATIONF ront Matter