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

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1 8506 Annotated List Second Supplement to USP 40 NF 35 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. Indicators General Chapters Phenolphthalein, 8628 Test Solutions M Acetic Acid TS (new), 8628 General Tests and Assays 0.3 N Acetic Acid TS (new), N Hydrochloric Acid TS (new), N Hydrochloric Acid TS (new), 8629 Biological Tests and Assays 0.75 M Phosphoric Acid TS (new), Calcium Pantothenate Assay, M Phosphoric Acid TS (new), Dexpanthenol Assay, % Trifluoroacetic Acid TS (new), Medical Devices Bacterial Endotoxin and Volumetric Solutions Pyrogen Tests, 8583 Preparation of Devices: Standard Methods and Demonstation of Continued Suitability Chemical Tests and Assays 503 Acetic Acid in Peptides, 8586 Introduction 0.05 M Barium Perchlorate VS (new), 8629 Reference Tables Container Specifications for Capsules and Tablets Trifluoroacetic Acid (TFA) in Peptides, Cinoxacin Capsules (deleted), Eleuthero Root and Rhizome Dry Extract Capsules Introduction, 8634 Physical Tests and Determinations Eleuthero Root and Rhizome Dry Extract Tablets 771 Opthalmic Products Quality Tests, 8589, 8634 Drug Product Quality Eleuthero Root and Rhizome Powder Capsules 781 Optical Rotation, 8595, 8634 Introduction Moxifloxacin Tablets, 8637 Nevirapine Extended-Release Tablets, 8637 General Information Reserpine and Hydrochlorothiazide Tablets (deleted), Tablet Compression Characterization Ziprasidone Capsules, 8641 (new), 8597 Description and Relative Solubility of USP and NF 1080 Bulk Pharmaceutical Excipients Certificate of Analysis, Sterilization Cycle Development (new), Sterilizing Filtration of Gases (new), 8620 Articles Esomeprazole Strontium, 8662 Fingolimod Hydrochloride, 8664 Linezolid, 8673 Methacrylic Acid Copolymer (deleted), 8675 Nilutamide, 8678 Reagents, Indicators, and Monographs (USP 40) Solutions Reagent Specifications Butylparaben (new), 8627 Desoxycorticosterone Acetate (new), 8627 Dihydroxybenzaldehyde (new), 8628 Dihydroxyphenylacetone (new), 8628 Hydroxypropyl-β-cyclodextrin, 8628 Linolenic Acid (new), 8628 (R)-( )-Littorine Hydrochloride (new), 8628 Mercurous Nitrate Dihydrate, 8628 p-methoxyacetophenone (new), 8628 Methyl cis-11-eicosenoate (new), 8628 Methyl 12-Ketostearate (new), 8628 Nickel Sulfate, 8628 n-octane (new), 8628 Polyvinyl Alcohol, 8628 Tetraethylammonium Chloride (new), 8628 Triazolam (new), 8628 Acetaminophen and Aspirin Tablets, Aminophenol in Acetaminophen-Containing Drug Products Acetaminophen, Aspirin, and Caffeine Tablets, Aminophenol in Acetaminophen-Containing Drug Products Acetylcysteine Compounded Solution (new), 8705 Acitretin Capsules, 8706

2 Second Supplement to USP 40 NF 35 Annotated List 8507 Almotriptan Tablets, 8708 Aspirin Atropine Sulfate Ophthalmic Ointment, 8726 Anagrelide Capsules, 8710 and Packaging and Storage Atropine Sulfate Ophthalmic Solution, 8728 Anastrozole Tablets, 8712 Infrared Absorption, Packaging and Storage Antipyrine and Benzocaine Otic Solution, 8714 Betamethasone Dipropionate Topical Aerosol (de- leted), 8729, (deleted), and Test C Candesartan Cilexetril Tablets, 8730 Carbidopa and Levodopa Tablets, 8732 Ascorbic Acid Compounded Oral Solution (new), 8716 Aspirin Boluses, 8717 Cetylpyridinium Chloride, 8734 Aspirin Delayed-Release Capsules, 8718 Organic Impurities Cinoxacin (deleted), 8735 Cinoxacin Capsules (deleted), 8736 Clarithromycin Extended-Release Tablets, 8736, Procedure, Apparatus 1 and Ap- paratus 2, Delayed-Release Dosage Forms, Clonazepam Orally Disintegrating Tablets, 8740 Method A Procedure Aspirin Tablets, 8719 Cyclophosphamide Tablets, 8741 Buffered Aspirin Tablets, 8720 Infrared Absorption, Aspirin Delayed-Release Tablets, 8721 Uniformity of Dosage Units Cytarabine, 8742 Infrared Absorption,, Procedure, Apparatus 1 and Ap- paratus 2, Delayed-Release Dosage Forms, Organic Impunities Method B Procedure Decoquinate Type A Medicated Article, 8744 Aspirin Effervescent Tablets for Oral Solution, 8722 Desoxycorticosterone Acetate (deleted), 8745 Desoxycorticosterone Acetate Injection (deleted), 8745 Desoxycorticosterone Acetate Pellets (deleted), Aspirin Extended-Release Tablets, Dextromethorphan, 8746 Aspirin, Alumina, and Magnesia Tablets, 8724 Melting Range or Temperature, Procedures, Class I (deleted) and Optical Rotation, Proce- dures, Specific Rotation (deleted)

3 8508 Annotated List Second Supplement to USP 40 NF 35 Dextromethorphan Hydrobromide, 8747 Eprinomectin, 8775,, and Test C (deleted) Limit of Residual Solvents (deleted) Optical Rotation, Procedures, Specific Rotation Eprosartan Mesylate (new), 8777 (deleted) Esomeprazole Strontium (new), 8779 Estradiol and Norethindrone Acetate Tablets, 8781 Dienestrol (deleted), 8749 Dienestrol Cream (deleted), 8749 Dipyridamole, 8750 Organic Impurities Estradiol Transdermal System, 8784 Drug Release Divalproex Sodium, 8751 CHEMICAL INFORMATION Estradiol Valerate, 8787 Identification Tests General, Chemical Iden- tification Tests, Sodium, and Test C Ordinary Impurities (deleted), Organic Impu- rities, and Limit of Estradiol Divalproex Sodium Extended-Release Tablets, (deleted) 8752 Melting Range or Temperature, Class Ia (de- leted) and Optical Rotation, Procedures, Spe- cific Rotation Exenatide (new), 8789 Docetaxel Injection, 8760 Fenofibrate Tablets, 8791 Fingolimod Hydrochloride (new), 8794 Donepezil Hydrochloride Tablets, 8762 Flutamide Capsules, 8795 Fluvoxamine Maleate, 8797 Doxorubicin Hydrochloride Injection, 8766 Organic Impurities Melting Temperature (deleted) Doxycycline Capsules, 8767 Folic Acid Compounded Oral Solution (new), 8798 Hydralazine Hydrochloride, 8799 Organic Impurities and Limit of Hydrazine (deleted) Water-Insoluble Substances (deleted) Doxycycline Calcium Oral Suspension, 8769 Hydralazine Hydrochloride Tablets, 8801 Hydrocortisone Injectable Suspension (deleted), 8802 Dutasteride, 8771 Hydrocortisone Acetate Injectable Suspension (de- leted), 8802 Water Determination, Method I, Method Ic Hydrocortisone Acetate Ophthalmic Suspension (deleted), 8803 Insulin Aspart, 8803 Entecavir Tablets, 8773 Physicochemical Analytical Procedures for In- sulins, Peptide Mapping,

4 Second Supplement to USP 40 NF 35 Annotated List 8509 PRODUCT-RELATED SUBSTANCES AND Nitrofurazone, 8836 Product-Related Substances Test C (deleted) Loss on Drying Ordinary Impurities (deleted), Limit of 5-Ni- Lamotrigine Extended-Release Tablets, 8805 tro-2-furfuraldazine (deleted), and Organic Impurities Ondansetron Compounded Topical Gel (new), Leucovorin Calcium Compounded Oral Suspen sion (new), 8809 Ondansetron Orally Disintegrating Tablets, 8838 Linezolid (new), 8809 Lorazepam, 8811 Ultraviolet Absorption, Infrared Absorption, Oxymorphone Hydrochloride Tablets, 8840 Methylnaltrexone Bromide (new), 8812 Metoprolol Tartrate Tablets, 8814 Oxymorphone Hydrochloride Extended-Release Tablets, 8842 (deleted),, and Test C Packaging and Storage and USP Reference Standards Paroxetine Extended-Release Tablets, 8845 Metoprolol Tartrate and Hydrochlorothiazide Tab- lets, 8816 Uniformity of Dosage Units, Content Phenytoin Chewable Tablets, 8849 Uniformity Milbemycin Oxime (new), 8819 Monensin Type A Medicated Article, 8821 and Pramipexole Dihydrochloride, 8851 Morphine Sulfate Extended-Release Capsules, 8822 Limit of Pramipexole Related Compound D and Organic Impurities Limit of Palladium (deleted) Moxifloxacin Tablets (new), 8825 Promethazine Hydrochloride Oral Solution, 8853 Nandrolone Phenpropionate (deleted), 8827 Nandrolone Phenpropionate Injection (deleted), Protriptyline Hydrochloride Tablets, Narasin Type A Medicated Article, 8828 Nevirapine Extended-Release Tablets (new), 8829 Niacin Extended-Release Tablets, 8831 Packaging and Storage Quinine Sulfate Capsules, 8856 Nimodipine, 8835 Reserpine Injection (deleted), 8858 Reserpine Oral Solution (deleted), 8859 Organic Impurities Reserpine and Hydrochlorothiazide Tablets (de- leted), 8859 Optical Rotation, Procedures, Specific Rotation Riluzole Tablets, 8861

5 8510 Annotated List Second Supplement to USP 40 NF 35 Zonisamide Capsules, 8886 Infrared Absorption, Salmeterol Xinafoate, 8862 Infrared Absorption, Sodium Acetate, 8864 Identification Tests General, Chemical Iden- Monographs (Dietary Supplements) tification Tests, Acetate, Chia Seed Oil (new), 8889 Chondroitin Sulfate Sodium, Shark, 8890 Chloride and Sulfate, Chloride; Chloride and Sulfate, Sulfate; and Aluminum Sodium Nitrite, 8865 Specific Disaccharides, Test C Disaccharide Composition Test C Eleuthero Root and Rhizome, 8893 Bacterial Endotoxins Test, Microbial HPTLC for Articles of Botanical Origin, Enumeration Tests, ph, and Insoluble Matter Eleuthero Root and Rhizome Dry Extract, 8894 Sodium Nitrite Injection, 8868 Test C Thin-Layer Chromatographic Identification Test, Bacterial Endotoxins Test Alcohol Determination, Method II (deleted) Silver Sulfadiazine, 8869 and Other Requirements (deleted),, and Identification Tests Gen- eral, Chemical Identification Tests, Silver, Test Eleuthero Root and Rhizome Dry Extract Capsules C (new), 8896 Eleuthero Root and Rhizome Dry Extract Tablets (new), 8897 Organic Impurities Eleuthero Root and Rhizome Powder, 8898 Particle Size (deleted) HPTLC for Articles of Botanical Origin, Terbinafine Tablets, 8871 Eleuthero Root and Rhizome Powder Capsules (new), 8899 Packaging and Storage Lactobacillus paracasei LPC-37 (new), 8901 Teriparatide, 8872 Red Clover Aerial Parts Isoflavone Aglycones Dry Extract (new), 8903 Rhodiola crenulata Root and Rhizome (new), 8904 and Bioidentity, Test C Rhodiola crenulata Root and Rhizome Dry Extract (new), 8906 PRODUCT-RELATED SUBSTANCES AND Rhodiola crenulata Root and Rhizome Powder (new), 8907 Salix Species Bark (new), 8908 Bacterial Endotoxins Test and Microbial Enu- Salix Species Bark Dry Extract (new), 8910 meration Tests Salix Species Bark Powder (new), 8912 Teriparatide Injection (new), 8877 Theophylline Oral Solution, 8880 Excipients Ziprasidone Capsules (new), 8882 Zolpidem Tartrate Tablets, 8884 Coating Agent Methacrylic Acid Copolymer (deleted), 8916 Diluent Methacrylic Acid Copolymer (deleted), 8917 Methacrylic Acid and Ethyl Acrylate Copolymer (new), 8917

6 Second Supplement to USP 40 NF 35 Annotated List 8511 Methacrylic Acid and Methyl Methacrylate Copolymer (new), 8917 Film-Forming Agent Methacrylic Acid Copolymer (deleted), 8919 Wet Binder Methacrylic Acid Copolymer (deleted), 8924 Methacrylic Acid and Ethyl Acrylate Copolymer (new), 8924 Methacrylic Acid and Methyl Methacrylate Copolymer (new), 8924 Monographs (NF 35) Almond Oil, 8925 Identity by Triglyceride Profile, Aluminum Monostearate, 8927 and Canola Oil, 8929 Identity by Triglyceride Profile, Hydrogenated Castor Oil, 8929 CHEMICAL INFORMATION Melting Range or Temperature, Class II (deleted); Fats and Fixed Oils, Procedures, Acid Value; Fats and Fixed Oils, Procedures, Hydroxyl Value Cholesterol, 8932 Limit of Related Sterols and Other Organic Impurities Corn Oil, 8934 Identity by Triglyceride Profile, Other Requirements Cottonseed Oil, 8935 Identity by Triglyceride Profile, Other Requirements Dichlorodifluoromethane (deleted), 8935 Dichlorotetrafluoroethane (deleted), 8936 Octyldodecanol, 8937 Limit of Related Fatty Alcohols and Organic Impurity Test 2: Limit of Branched Chain Fatty Alcohols and Branched Chain Aldehyde and Peanut Oil, 8939 Identity by Triglyceride Profile, Polyoxyl 35 Castor Oil, 8940 CHEMICAL INFORMATION Constituting Fatty Acids, and Test C Ethylene Oxide and Dioxane and Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances Viscosity Capillary Methods Polyoxyl 40 Hydrogenated Castor Oil, 8942 CHEMICAL INFORMATION, and Indication of Saturation, Test C Ethylene Oxide and Dioxane, Method I and Limit of Nickel Fats and Fixed Oils, Procedures, Hydroxyl Value and Fats and Fixed Oils, Procedures, Io- dine Value (deleted) Sodium Hydroxide, 8944 ph, Potassium Sodium Lauryl Sulfate, 8946 Infrared Absorption,,, Test C, Test D, and Test E Sodium Chloride

Commentary. USP 40 NF 35, Second Supplement. June 1, 2017

Commentary. USP 40 NF 35, Second Supplement. June 1, 2017 Commentary USP 40 NF 35, Second Supplement June 1, 2017 In accordance with USP s Rules and Procedures of the Council of Experts ( Rules ) and except as provided in Section 7.02 Accelerated Revision Processes,