ANNOTATED LIST. Monographs, General Chapters, Reagents, and Tables Affected by Changes Appearing in This Supplement

Transcription

1 8246 Annotated List First Supplement to USP 41 NF 36 ANNOTATED LIST Monographs, General Chapters, Reagents, and Tables Affected by Changes Appearing in This Supplement Page 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 or deleted from an existing section, it is labeled 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. 2-Ethylhexanoic Acid (new), 8500 General Chapters (±)-1-(9-Fluorenyl)ethanol (new), 8500 (+)-1-(9-Fluorenyl)ethyl Chloroformate Solution (new), 8500 General Tests and Assays Fluoroandrostadiene Carboxylic Acid (new), 8501 Gadolinium Sulfate, % Hydrochloric Acid (new), 8501 Biological Tests and Assays Isopropyl Stearate (new), Glucagon Bioidentity Tests, 8627 Isostearic Acid (new), 8501 Introduction and Procedure Lithium Sulfate, 8501 Chemical Tests and Assays 198 Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides Used in Vaccine Manufacture (new), 8633 Physical Tests and Determinations 724 Drug Release, 8637 General Drug Release Standards 741 Melting Range or Temperature, Mercaptopropionic Acid (new), 8501 Methyl Isobutyrate (new), Methyl-2-pentanone (new), Morpholine Propane Sulfonic Acid (new), 8502 Nitric Acid, Ultratrace (new), 8502 Petroleum Ether (new), 8502 Phenylacetic Acid (new), 8502 Sodium Phosphate (new), 8502 Sulfan Blue (new), 8502 Sulfuric Acid, Diluted, 8502 General Information 1,1,3,3-Tetramethylbutylamine (new), 8502 Tetramethylethylenediamine (new), Pharmaceutical Dosage Forms, 8648 n-tricosane (deleted), Water for Pharmaceutical Purposes, 8674 Water, Ammonia-Free, 8502 Waters Used for Pharmaceutical Manufacturing Test Solutions and Testing Purposes; Validation and Qualifica- 4 N Hydrochloric Acid TS (new), 8502 tion of Water Purification, Storage, and Distri- 0.1 M Monobasic Sodium Phosphate TS (new), bution Systems; Design and Operation of Puri fied Water and Water for Injection Systems; 0.05 M Monobasic Sodium Phosphate TS (new), Sampling; Chemical Evaluations; Microbial Eval uations; and Alert and Action Levels and 0.1 N Sodium Chloride TS (new), 8502 Specifications 10 N Sulfuric Acid TS (new), 8502 Volumetric Solutions Dietary Supplements 2040 Disintegration and of Dietary Supplements, N Ceric Sulfate VS, M Sodium Thiosulfate VS, N Sulfuric Acid VS (new), 8503 Chromatographic Columns L52, 8503 L86, 8503 L107 (new), 8503 Reagents, Indicators, and L110 (new), 8503 Solutions L112 (new), 8504 Reference Tables Reagent Specifications Ammonium Hydrogen Difluoride (new), 8499 Benzil (new), 8499 Container Specifications for Capsules and Tablets Blood Group A 1 Red Blood Cells and Blood Group Amlodipine and Atorvastatin Tablets (new), 8505 B Red Blood Cells (deleted), 8500 Cholecalciferol Tablets (new), 8507 Cadmium Nitrate, 8500 Raltegravir Tablets (new), Chlorobenzophenone (new), 8500 Raltegravir Tablets, Chewable (new), Chloroethylamine Monohydrochloride, 8500 Rosuvastatin Tablets (new), 8513 Cupric Nitrate Hydrate (deleted), 8500 Tocainide Hydrochloride Tablets (deleted), Cyclohexylpropionic Acid (new), 8500 Valerian Root Dry Extract Capsules (new), 8514 L-Cystine, 8500 Valerian Root Powder Capsules (new), 8514 Deschloroclotrimazole (new), 8500 Description and Relative Solubility of USP and NF N,N -Diisopropylethylenediamine (new), 8500 Dimethylcarbonate (new), 8500 Dimidium Bromide (new), 8500 Articles Acamprosate Calcium (new), 8516

2 First Supplement to USP 41 NF 36 Annotated List 8247 Brimonidine Tartrate (new), 8523 Clomipramine Hydrochloride, 8529 Duloxetine Hydrochloride, 8535 Brimonidine Tartrate (new), 8298 Fluphenazine Decanoate (new), 8539 Calcium Citrate Malate (new), 8299 Fluphenazine Hydrochloride, 8539 Carbidopa and Levodopa Extended-Release Tab- Glyceryl Tricaprylate (new), 8540 lets, 8301 Isopropyl Isostearate (new), 8545 Isostearyl Isostearate (new), 8545 Solifenacin Succinate (new), 8567 Carprofen, 8306 Acamprosate Calcium (new), 8263 Acetaminophen Oral Suspension, 8264 Limit of Acetone and Methylene Chloride (deleted) Acetaminophen Tablets, 8266 Cetylpyridinium Chloride, 8308 Test B Cholecalciferol Tablets (new), 8309 Chymotrypsin, 8310 Chymotrypsin for Ophthalmic Solution, 8311 Amitriptyline Hydrochloride, 8268 Clarithromycin, 8312 Amitriptyline Hydrochloride Injection (deleted), Colchicine, Amlodipine and Atorvastatin Tablets (new), 8270 Amlodipine and Valsartan Tablets, 8274 Limit of Ethyl Acetate Cortisone Acetate Injectable Suspension (deleted), 8315 Cyclopentolate Hydrochloride, 8316 and Identification Tests Amlodipine, Valsartan, and Hydrochlorothiazide General, Test C Tablets, 8278 Dexamethasone Sodium Phosphate Inhalation Aerosol (deleted), 8317 Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 8317 Amoxicillin, 8284 Procedure 2: Timolol Anthrax Vaccine Adsorbed (deleted), 8285 Aripiprazole Tablets, 8288 Doxycycline Hyclate Capsules, 8320 Infrared Absorption, Azithromycin Tablets, 8291 Doxycycline Hyclate Tablets, 8322 Aztreonam, 8294 Infrared Absorption, Doxycycline Hyclate Delayed-Release Tablets, Baclofen Tablets, Duloxetine Delayed-Release Capsules, 8328 BCG Vaccine (deleted), 8297 Benzethonium Chloride, 8297 Estradiol Benzoate, 8334 Infrared Absorption, Test B (added) Monographs (USP 41)

3 8248 Annotated List First Supplement to USP 41 NF 36 Limit of Methanol and Dichloromethane Miconazole Nitrate, 8353 Eszopiclone Tablets, 8335 Optical Rotation, Specific Rotation (added) Glycine, 8337 Miconazole Nitrate Topical Powder, 8355 Related Compounds (added) Hydrocortisone Acetate Ophthalmic Ointment (added) (deleted), 8339 Hydroxyzine Pamoate Oral Suspension (deleted), Minocycline Hydrochloride, Isoleucine, 8340 Related Compounds Montelukast Sodium Oral Granules, 8358 Levocarnitine, 8341 Moxifloxacin Hydrochloride, 8361 Enantiomeric Purity Enantiomeric Purity (added) Naproxen Sodium Tablets, 8363 Optical Rotation, Specific Rotation (deleted) Nicotine Transdermal System, 8365 Packaging and Storage Lidocaine, 8343 Drug Release (added) (added) (deleted) Nifedipine Extended-Release Tablets, 8369 Lidocaine Hydrochloride Oral Topical Solution, 8344 Norelgestromin, 8376 Octinoxate, 8377 Lidocaine Hydrochloride Topical Solution, 8346 Octisalate, 8378 Mebendazole Tablets, 8347 Octocrylene, 8379 Olmesartan Medoxomil Tablets, 8380 Uniformity of Dosage Units (added) Meloxicam Oral Suspension, 8349 Omega-3-Acid Ethyl Esters, 8382 Test A Labeling Omega-3-Acid Ethyl Esters Capsules, 8385 Labeling Metaproterenol Sulfate Inhalation Aerosol (de- Oxybutynin Chloride Extended-Release Tablets, leted), Methotrexate Injection, 8352 Pantoprazole Sodium, 8392 (added)

4 First Supplement to USP 41 NF 36 Annotated List 8249 Test C (added) Pentazocine, 8394 Sodium Fluoride Oral Solution, 8422 Test A Ordinary Impurities (deleted) and Organic Impurities (added) Sodium Fluoride and Acidulated Phosphate Topiand Bacterial Endotoxins Test (added) cal Solution, 8423 Perphenazine Injection (deleted), 8396 Perphenazine Oral Solution (deleted) 8396 Other Requirements (deleted) Perphenazine Syrup (deleted), 8397 Phenoxybenzamine Hydrochloride Capsules, 8397 Labeling and Somatropin, 8424 Pilocarpine Hydrochloride Tablets, 8399 Limit of High Molecular Weight Proteins Total Protein Content Sumatriptan Nasal Spray, 8426 Pralidoxime Chloride, 8401 (added) Taurine, 8428 Pralidoxime Chloride for Injection, 8402 Terbutaline Sulfate Inhalation Aerosol (deleted), 8429 Tetracycline, 8430 Completeness of Solution (deleted) Tetrahydrozoline Hydrochloride Ophthalmic Solu- Prasugrel Hydrochloride (new), 8403 tion, 8431 Pravastatin Sodium, 8406 Identification Tests General, Test B and Test (added) C (added) Packaging and Storage Tiamulin, 8433 Limit of Alcohol Pyridostigmine Bromide Tablets, 8408 Limit of Alcohol and Toluene Tiamulin Fumarate, 8434 Raltegravir Tablets (new), 8409 Raltegravir Chewable Tablets (new), 8411 Rizatriptan Benzoate Orally Disintegrating Tablets, 8413 Limit of Residual Solvents (deleted) and Or- ganic Impurities Tocainide Hydrochloride (deleted), 8436 Tocainide Hydrochloride Tablets (deleted), 8436 Rosuvastatin Calcium (new), 8415 Tolterodine Tartrate, 8437 Rosuvastatin Tablets (new), 8417 Salmeterol Xinafoate, 8419 Tranexamic Acid Injection (new), 8439 Tranylcypromine Tablets, 8440 Scopolamine Hydrobromide, 8420 Trazodone Hydrochloride Tablets, 8442

5 8250 Annotated List First Supplement to USP 41 NF 36 Coix Seed Powder (new), 8460 Test A Flax Seed Oil, 8462 Fats and Fixed Oils, Peroxide Value; Fats and Fixed Oils, Iodine Value; Fats and Fixed Oils, Triamterene, 8444 Saponification Value; and Fats and Fixed Oils, Unsaponifiable Matter Menaquinone-4 (new), 8462 Methylcobalamin, 8463 Methylcobalamin Tablets, 8464 Verapamil Hydrochloride Extended-Release Tab- STRENGTH lets, 8446 Salix Species Bark, 8465 Salix Species Bark Dry Extract, 8467 Salix Species Bark Powder, 8469 Valerian Root Dry Extract Capsules (new), 8471 Valerian Root Powder Capsules (new), 8472 Packaging and Storage and USP Reference Monographs (NF 36) Standards Xylazine, 8450 and Thin-Layer Chromatographic Identification Test, Test C (deleted) Limit of Acetone and Isopropyl Alcohol and Monographs (Dietary Supplements) Ascorbic Acid Chewable Gels (new), 8453 Cholecalciferol Chewable Gels (new), 8454 Coffee Fruit Dry Extract (new), 8455 Coix Seed (new), 8457 Ethylcellulose, 8485 Labeling and Glyceryl Tricaprylate (new), 8487 Isopropyl Isostearate (new), 8489 Methyl Salicylate, 8490 Polydextrose, 8491 Chromatographic Identity, Test E (added) Squalane, 8494