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General Notices, Monographs, General Chapters, Reagents ...

XxxviAnnotated ListUSP 40 ANNOTATED LISTG eneral Notices, Monographs, General Chapters, Reagents , and TablesAffected by Changes Appearing in USP 40 Page citations refer to the pages of USP 40. 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 NoticesReagents, Indicators, andSolutionsGeneral Notices, 33. Conformance to Standards; 5. MonographReagent SpecificationsComponents; 6. Testing Practices and Proce- Reagents Introduction, 2323dures; and 8.

Tramadol Hydrochloride Extended-Release Tablets, Aminophylline Tablets, 2742 2575 IDENTIFICATION PERFORMANCE TESTS Infrared Absorption, Test A and Test B Dissolution ASSAY IMPURITIES IMPURITIES Alfuzosin Hydrochloride Extended-Release Tablets, ADDITIONAL REQUIREMENTS 2626 Packaging and Storage and USP Reference …

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Transcription of General Notices, Monographs, General Chapters, Reagents ...

1 XxxviAnnotated ListUSP 40 ANNOTATED LISTG eneral Notices, Monographs, General Chapters, Reagents , and TablesAffected by Changes Appearing in USP 40 Page citations refer to the pages of USP 40. 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 NoticesReagents, Indicators, andSolutionsGeneral Notices, 33. Conformance to Standards; 5. MonographReagent SpecificationsComponents; 6. Testing Practices and Proce- Reagents Introduction, 2323dures; and 8.

2 Terms and Definitions4. DefinitionsButylated Hydroxytoluene (new), 2341 General ChaptersCopper Sulfate Pentahydrate (new), 2348 Cupric Nitrate, 23481,1-Cyclobutanedicarboxylic Acid (new), 2349 Hydroxypropyl Cellulose (new), 2364 General Tests and AssaysIsonicotinic Acid, 2366(R)-(+)-Limonene (new), 2367 General Requirements for Tests and AssaysLithium (new), 2368 1 Injections and Implanted Drug ProductsMalonic Acid (new), 2368(Parenterals) Product Quality Tests, 67D-Mannitol (new), 2369 Nickel Nitrate Hexahydrate (new), 2373 Biological Tests and Assays(R)-(-)-a-Phellandrene (new), 2378 Collagenase I (new), 180(+)-a-Pinene (new), 2380 Collagenase II (new), 185b-Pinene (new), 2380 127 Flow Cytometric Enumeration of CD34+Polysorbate 80 (new), 2381 Cells (new), 216 Propionic Acid (new), 2383 151 Pyrogen Test, 234 Sabinene (new), 2386 IntroductionSodium 1-Dodecanesulfonate (new), 2391 165 Prekallikrein Activator (new), 241 Tetrabutylammonium Hydroxide 30-Hydrate,Chemical Tests and Assays2397 481 Riboflavin Assay, 386 Tetrahydrofuran, 2398 ASSAYW ater (new), 2405 531 Thiamine Assay, 407 Water, Carbon Dioxide-Free, 2405 ASSAYW ater, Deaerated, 2405 Physical Tests and DeterminationsWater, Organic-Free (new), 2405 659 Packaging and Storage Requirements, 529 Water, Particle-Free (new)

3 , 2405 670 Auxiliary Packaging Components, 558 Test Solutions 821 Radioactivity, 7511 M Acetic Acid TS (new), 24112 M Acetic Acid TS (new), 2412 General Information1 M Ammonium Hydroxide TS (new), 24132 M Ammonium Hydroxide TS (new), M Edetate Disodium TS (new), 2415 1015 Automated Radiochemical Synthesis N Hydrochloric Acid TS (new), 2416ratus (deleted), N Hydrochloric Acid TS (new), 2416 1039 Chemometrics (new), N Hydrochloric Acid TS (new), 2416 1602 Spacers and Valved Holding M Phosphoric Acid TS (new), 2419 Used with Inhalation Aerosols M Phosphoric Acid TS (new), 2419 Tests (new), 19881 N Phosphoric Acid TS (new), 2419 1821 Radioactivity Theory and Practice (new),20% Phosphoric Acid TS (new), N Potassium Hydroxide TS (new), 2420 1823 Positron Emission Tomography Drugs In-45% Potassium Hydroxide TS (new), 2420formation (new), M Monobasic Potassium Phosphate TS(new), 2420 Dietary M Dibasic Potassium Phosphate TS (new),2420 2251 Screening for Undeclared Drugs and N Sodium Hydroxide TS (new), 2421 Analogues, N Sodium Hydroxide TS (new), 24212 N Sodium Hydroxide TS (new), N Sodium Hydroxide TS (new), 242110 N Sodium Hydroxide TS (new), 24211 M Sulfuric Acid TS (new), N Sulfuric Acid TS (new)

4 , 2422 Front Matter7484 Annotated ListNF 35 ANNOTATED LISTG eneral Notices, Monographs, General Chapters, Reagents , and TablesAffected by Changes Appearing in NF 35 Page citations refer to the pages of NF 35. Note In the list below, if a section is new or if a subsection is added to or deletedfrom an existing section, it is labeled as such in parentheses after the section or subsection name. Items on this list that appearwithout the designation new , added , or deleted are items in which changes have been made to existing official TESTSE xcipientsContent of Water-Soluable Material and Mi-crobial Enumeration Tests and Tests for Speci-fied MicroorganismsFlavors and FragranceEucalyptus Oil (new), 7663 Eucalyptus Oil, 7489 Glyceryl Tristearate, 7691 Sodium Succinate, 7489 IDENTIFICATIONpH Modifier (Acidifying Agent/Alkalizing Agent/Monosodium Glutamate, 7771 Buffering Agent)CHEMICAL INFORMATION (added)Sodium Succinate, 7490 IDENTIFICATIONADDITIONAL REQUIREMENTSM onographs (NF 35)USP Reference Standards (added)

5 Potassium Hydroxide, 7844 Tribasic Calcium Phosphate, 7552 DEFINITIONIDENTIFICATIONIDENTIFICATIONC roscarmellose Sodium, 7625pH, Test B (added)INTRODUCTION (added)ASSAYIDENTIFICATIONIMPURITIESTest CSodium Succinate (new), 7890 IMPURITIESS odium Chloride and Sodium GlycolateNF MonographsUSP 40 Annotated N Sulfuric Acid TS (new), M Tetramethylammonium Bromide VS, 24352 N Sulfuric Acid TS (new), M Tetramethylammonium Chloride VS, M Tetrabutylammonium Hydrogen N Titanium Trichloride VS, 2435TS (new), M Zinc Sulfate VS, M Zinc Sulfate VS (new), 2436 Volumetric Solutions2 N Acetic Acid VS, 2424 Chromatographic N Ammonium Thiocyanate VS, 2424L19, M Bismuth Nitrate VS, 2424L22, N Bromine VS, 2424L40, N Ceric Ammonium Nitrate VS, 2424L45, N Ceric Sulfate VS, 2424L51, N Cupric Nitrate VS, 2425L54, 2438 Cupric Tartrate, Alkaline, Solution (Fehling s Solu-L56, 2438tion), 2425L80, M Edetate Disodium VS, 2425L90 (new), M Edetate Disodium VS, 2426L91 (new), N Ferric Ammonium Sulfate VS, N Ferrous Ammonium Sulfate VS, 2426 Reference N Hydrochloric Acid VS (new), N Hydrochloric Acid VS (new)

6 , N Hydrochloric Acid VS, 2427 Container Specifications for Capsules and Tablets1 N Hydrochloric Acid VS, 2427 Biperiden hydrochloride Tablets (deleted), M Alcoholic Hydrochloric Acid VS, 2427 Quetiapine Extended-Release Tablets (new), N Hydrochloric Acid in Methanol VS, 2427St. John s Wort Flowering Top Dry Extract N Iodine VS, 2427sules (new), N Iodine VS, 2427St. John s Wort Flowering Top Dry Extract N Iodine VS, 2427(new), M Lead Nitrate VS, 2428 Tienchi Ginseng Root and Rhizome Powder M Lead Perchlorate VS, 2428sules (new), M Lead Perchlorate VS, 2428 Tienchi Ginseng Root and Rhizome Powder N Lithium Methoxide in Chlorobenzene VS,lets (new), 24512428 Tienchi Ginseng Root and Rhizome Dry N Lithium Methoxide in Methanol VS, 2428 Capsules (new), N Lithium Methoxide in Methanol VS, 2429 Tienchi Ginseng Root and Rhizome Dry N Lithium Methoxide in Toluene VS, 2429 Tablets (new), M Magnesium Chloride VS, 2429 Description and Relative Solubility of USP and M Mercuric Nitrate VS, N Oxalic Acid VS, 2429 Doxercalciferol (new)

7 , N Perchloric Acid in Dioxane VS, 2429 Eucalyptus Oil (new), N Perchloric Acid in Glacial Acetic Acid VS,Ixabepilone (new), 24822430 Methacrylic Acid and Ethyl Acrylate N Potassium Arsenite VS, 2430 Dispersion, N Potassium Bromate VS, 2430 Methylene Blue, N Potassium Bromide Bromate VS, 2430 Pemetrexed Disodium (new), N Potassium Dichromate VS, 2430 Perindopril Erbumine (new), M Potassium Ferricyanide VS, 2431 Sodium Succinate (new), M Alcoholic Potassium Hydroxide VS, N Alcoholic Potassium Hydroxide VS, 2431 Monographs (USP 40) N Methanolic Potassium Hydroxide VS, 24311 N Potassium Hydroxide VS, M Potassium Iodate VS, 2431 Acebutolol hydrochloride Capsules, N Potassium Permanganate VS, N Potassium Thiocyanate VS, N Silver Nitrate in Isopropyl Alcohol VSPERFORMANCE TESTS(new), N Silver Nitrate VS, N Silver Nitrate VS (new), 2432 Acetaminophen, Chlorpheniramine Maleate, M Sodium Arsenite VS, 2432 Dextromethorphan Hydrobromide Tablets, 25611 N Sodium Hydroxide VS, N Alcoholic Sodium Hydroxide VS, 2433 Acetaminophen, Chlorpheniramine Maleate, N Sodium Hydroxide VS (new)

8 , 2433and Dextromethorphan N Sodium Methoxide in Methanol VS, N Sodium Methoxide in Toluene VS, 24334-Aminophenol in M Sodium Nitrite VS, 2433 Drug Products (added) M Sodium Tetraphenylboron VS, 2434 ADDITIONAL N Sodium Thiosulfate VS, 2434 USP Reference StandardsStandard Dichlorophenol Indophenol Solution,Acetaminophen and Codeine Phosphate Oral So-2434lution, 25641 N Sulfuric Acid VS, N Sulfuric Acid in Alcohol VS, 2434 Acetaminophen and Codeine N Tetrabutylammonium Hydroxide VS, N Tetrabutylammonium Hydroxide in Metha-4-Aminophenol in Acetaminophen-Containingnol/Isopropyl Alcohol VS, 2435 Drug Products (added)Front MatterxxxviiiAnnotated ListUSP 40 Acetaminophen and Codeine Phosphate Oral Sus-ASSAY pension, 2565 SPECIFIC TESTSASSAYA cidityAcetaminophen and Codeine PhosphateAminobenzoate Potassium, 2720 IMPURITIESCHEMICAL INFORMATION4-Aminophenol in Acetaminophen-ContainingDEFINITIONDrug Products (added)IDENTIFICATIONA cetaminophen, Dextromethorphan Test A and Test BHydrobromide, Doxylamine Succinate, and Pseu-ASSAY doephedrine hydrochloride Oral Solution, 2567 IMPURITIESASSAYC hloride and Sulfate, Chloride; Chloride andAcetaminophen and DextromethorphanSulfate, Sulfate; Volatile Diazotizable Sub-Hydrobromidestances; Limit of Aniline and p-Toluidine.

9 AndIMPURITIESO rganic Impurities4-Aminophenol in Acetaminophen-ContainingADDITIONAL REQUIREMENTSDrug Products (added)USP Reference StandardsAcetaminophen and Diphenhydramine CitrateAminobenzoate Potassium Capsules, 2722 Tablets, 2569 IDENTIFICATIONASSAYTest B (added)Acetaminophen and Diphenhydramine CitrateASSAYIMPURITIESIMPURITIES4-Aminop henol in Acetaminophen-ContainingADDITIONAL REQUIREMENTSDrug Products (added)USP Reference StandardsAcetaminophen, Diphenhydramine Hydrochlo-Aminophylline, 2735ride, and Pseudoephedrine hydrochloride Tablets,IDENTIFICATION2570 Infrared Absorption, Test A and Test BASSAYASSAYA cetaminophen and DiphenhydramineOTHER COMPONENTSH ydrochlorideIMPURITIESIMPURITIESADDITION AL REQUIREMENTS4-Aminophenol in Acetaminophen-ContainingPackaging and Storage and USP ReferenceDrug Products (added)StandardsAcetaminophen and Pseudoephedrine Hydrochlo-Aminophylline Injection, 2737ride Tablets, 2571 IDENTIFICATIONASSAYI nfrared Absorption, Test B and Test CIMPURITIESASSAY4-Aminophenol in Acetaminophen-ContainingIMPURITIESDrug Products (added)

10 ADDITIONAL REQUIREMENTSA cetaminophen and tramadol hydrochloride Tab-Packaging and Storage and USP Referencelets, 2572 StandardsTITLEA minophylline Oral Solution, 2739 ASSAYIDENTIFICATIONOTHER COMPONENTSI nfrared Absorption, Test ALimit of p-Aminophenol (deleted)ASSAYIMPURITIESIMPURITIESADDITI ONAL REQUIREMENTSADDITIONAL REQUIREMENTSUSP Reference StandardsUSP Reference StandardsTramadol hydrochloride Extended-Release Tablets,Aminophylline Tablets, 27422575 IDENTIFICATIONPERFORMANCE TESTSI nfrared Absorptio


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