7624 Annotated List First Supplement to USP 39 NF 34 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. General Chapters Dietary Supplements General Tests and Assays 2251 Adulteration of Dietary Supplements with Drugs and Drug Analogs (new), 7821 Reagents, Indicators, and Apparatus for Tests and Assays 17 Prescription Container Labeling, 7691 Solutions Introduction and Prescription Container Label to Promote Understanding Microbiological Tests 55 Biological Indicators Resistance Performance Tests, 7694 Reagents Biological Tests and Assays Reagent Specifications 87 Biological Reactivity Tests, In Vitro, 7697 Benzethonium Chloride (new), 7844 ontrol and Casein Hammarsten, 7844 Chemical Tests and Assays β-lactoglobulin (new), 7844 191 Identification Tests General, 7701 β-lactoglobulin A (new), 7844 Introduction, Chemical Identification Tests, and 1-Naphthylacetic Acid (new), 7844 Instrumental Identification Tests Triethylammonium Acetate, 1 M (new), 7844 507 Protein Determination Procedures (new), Triphenylene (new), 7844 7712 Volumetric Solutions Physical Tests and Determinations Benzethonium Chloride, Two Hundred Fiftieth- 791 ph, 7717 Molar (new), 7844 Introduction, Instrument Requirements, Buffer Chromatographic Columns Solutions for Calibration of the ph Measure- L26, 7844 ment System, Calibration, and Operation L95 (new), 7844 800 Hazardous Drugs Handling in Healthcare L96 (new), 7845 Settings (new), 7721 L97 (new), 7845 L98 (new), 7845 General Information Reference Tables 1035 Biological Indicators for Sterilization (deleted), 7740 Container Specifications for Capsules and Tablets 1050.1 Design, Evaluation, and Characterization Abacavir and Lamivudine Tablets (new), 7847 of Viral Clearance Procedures (new), 7745 Candesartan Cilexetil Tablets (new), 7848 1065 Ion Chromatography, 7755 Diphenhydramine Hydrochloride and Ibuprofen 1176 Prescription Balances and Volumetric Ap- Capsules (new), 7850 paratus Used in Compounding, 7758 Oxtriphylline Delayed-Release Tablets (deleted), 1207 Package Integrity Evaluation Sterile Prod- 7853 ucts, 7764 Perindopril Erbumine Tablets (new), 7854 1207.1 Package Integrity Testing in the Product Rhodiola rosea Capsules (new), 7855 Life Cycle Test Method Selection and Validation Rhodiola rosea Tablets (new), 7855 (new), 7772 Sildenafil Tablets (new), 7855 1207.2 Package Integrity Leak Test Technologies Ubiquinol Capsules (new), 7856 (new), 7784 Zolmitriptan Tablets (new), 7857 1207.3 Package Seal Quality Test Technologies Description and Relative Solubility of USP and NF (new), 7801 Articles 1209 Sterilization Chemical and Physicochemi- Calcipotriene (new), 7866 cal Indicators and Integrators (deleted), 7804 Exemestane (new), 7879 1228 Depyrogenation (new), 7807 Lufenuron (new), 7888 1228.1 Dry Heat Depyrogenation (new), 7811 Nystatin, 7895 1229.5 Biological Indicators for Sterilization Palonosetron Hydrochloride (new), 7896 (new), 7815 Teniposide (new), 7912 1229.9 Physicochemical Integrators and Indica- Vardenafil Hydrochloride (new), 7916 tors for Sterilization (new), 7818 Zolmitriptan (new), 7917 1229.12 New Sterilization Methods (new), 7819
First Supplement to USP 39 NF 34 Annotated List 7625 Monographs (Dietary Monographs (NF 34) Supplements) Low-Substituted Carboxymethylcellulose Sodium, 7959 Calcium L-5-Methyltetrahydrofolate Capsules, 7919 Identification Tests General, Sodium, Test D STRENGTH Ethyl Oleate, 7960 Calcium L-5-Methyltetrahydrofolate Tablets, 7920 STRENGTH Ginger, 7921 Test A (added) and (added) (added) (added) Content of Gingerols and Gingerdiones and Limit of Shogaols Specific Gravity (deleted), Viscosity Capillary Methods or Viscosity Rotational Methods Limit of Shogaols (deleted), Fats and Fixed Oils, Acid Value (deleted), Fats and Fixed Oils, Saponification Labeling Value (deleted), Refractive Index (deleted), Powdered Ginger, 7923 Fats and Fixed Oils, Peroxide Value (added), and Water Determination (added) Stan- dards (added) Labeling Gelatin, 7962 Ginger Tincture, 7926 INTRODUCTION CONTAMINANTS For Non-Gelling Grades, Arsenic, Method II (deleted) Sulfur Dioxide, Peroxides, and Chromium Labeling Guar Gum, 7964 Glutathione, 7928 Ammonium Goldenseal, 7929 Isomalt, 7965 INTRODUCTION Powdered Goldenseal, 7930 Thin-Layer Chromatographic Identification Powdered Goldenseal Extract, 7932 Test, Test A Krill Oil, 7933 Limit of Nickel and Reducing Sugars Water Determination and Conductivity Fatty Acid Profile, Test A and Phospholipid Profile, Packaging and Storage Lecithin, 7968 Content of Total Phospholipids CONTAMINANTS Fats and Fixed Oils (deleted) Content of Acetone-Insoluble Matter Magnesium Stearate, 7971 Fats and Fixed Oils, Acid Value (deleted) and Fats and Fixed Oils, Unsaponifiable Matter Limit of Cadmium, Limit of Lead and Limit of (deleted) Nickel Rhodiola rosea Capsules (new), 7937 Rhodiola rosea Tablets (new), 7939 Microbial Enumeration Tests and Tests for Ribose (new), 7941 Specified Microorganisms Ubiquinol (new), 7942 Sodium Starch Glycolate, 7974 Ubiquinol Capsules (new), 7942 meso-zeaxanthin, 7943 Infrared Absorption, Test A Stereoisomeric Composition meso-zeaxanthin Preparation, 7945 Monographs (USP 39) Content of Total Carotenoids and Stereoiso- Abacavir and Lamivudine Tablets (new), 7977 meric Composition Acetaminophen and Caffeine Tablets, 7979 (added)
7626 Annotated List First Supplement to USP 39 NF 34 Acetazolamide, 7980 Buspirone Hydrochloride Tablets, 8012 (added) Acetazolamide for Injection, 7981 Calcium Pantothenate, 8014 Completeness of Solution (deleted) Acetazolamide Tablets, 7982 Optical Rotation, Specific Rotation, (added) (deleted) (added) OTHER COMPONENTS (added) (deleted) Adapalene Gel (new), 7983 Alendronate Sodium, 7984 Optical Rotation, Specific Rotation (deleted) Calcium Succinate (new), 8015 Alprazolam Extended-Release Tablets, 7986 Candesartan Cilexetil Tablets (new), 8016 Carbidopa and Levodopa Extended-Release Tab- lets, 8018 Labeling and Amiodarone Hydrochloride Injection (new), 7990 Amoxapine, 7992 Carbidopa and Levodopa Orally Disintegrating Tablets, 8023 Cetylpyridinium Chloride, 8025 Amoxicillin and Clavulanic Acid Extended-Release Tablets, 7993 Labeling (added) Melting Range or Temperature, Class 1 Argatroban (new), 7996 (deleted) Atomoxetine Hydrochloride, 7998 Clarithromycin, 8027 Clarithromycin Tablets, 8029 Atomoxetine Capsules, 8000 Clemastine Fumarate Tablets, 8031 Barium Hydroxide Lime, 8002 Test A and (added) and (added) Biological Indicator for Dry-Heat Sterilization, Pa- per Carrier (deleted), 8002 Uniformity of Dosage Units Biological Indicator for Ethylene Oxide Steriliza- (added) tion, Paper Carrier (deleted), 8003 Biological Indicators for Moist Heat, Dry Heat, Packaging and Storage and USP Reference and Gaseous Modes of Sterilization, Liquid Spore Suspensions (deleted), 8004 Cromolyn Sodium Ophthalmic Solution, 8032 Biological Indicators for Moist Heat, Dry Heat, and Gaseous Modes of Sterilization, Nonpaper Carriers (deleted), 8005 Biological Indicator for Steam Sterilization, Paper Carrier (deleted), 8006 Packaging and Storage and USP Reference Biological Indicator for Steam Sterilization, Self- Contained (deleted), 8007 Cyanocobalamin Tablets, 8034 Bisoctrizole, 8008 Procedure 1 and Procedure 2 (added) Limit of Bisoctrizole Related Compound A and Bisoctrizole Isomer Disintegration Buspirone Hydrochloride, 8009 Labeling (added) Dantrolene Sodium, 8035 (added) Identification Tests General, Sodium, and Test D (added)
First Supplement to USP 39 NF 34 Annotated List 7627 Fluorometholone Ophthalmic Suspension, 8067 Test A and (added) Digoxin, 8037 (added) Procedure, (deleted) Furosemide, 8068 Related Glycosides and Dihydroxyaluminum Sodium Carbonate, 8038 Gemfibrozil Tablets, 8069 Test A, (added), and (added) Glyburide and Metformin Hydrochloride Tablets, 8070 Diltiazem Hydrochloride Tablets, 8040 Glyburide, Test A Test A Glyburide and Metformin Hydrochloride (added) Packaging and Storage Diphenhydramine Hydrochloride and Ibuprofen Glyburide and Metformin Hydrochloride Capsules (new), 8042 Divalproex Sodium Extended-Release Tablets, 8043 Hydromorphone Hydrochloride, 8074 Docusate Potassium, 8051 Sulfate (deleted) and Dronedarone Hydrochloride (new), 8052 Dronedarone Tablets (new), 8053 Drospirenone and Ethinyl Estradiol Tablets, 8054 Iophendylate (deleted), 8076 Iophendylate Injection (deleted), 8077 Isoleucine, 8077 Duloxetine Hydrochloride, 8058 Related Compounds Edetate Disodium, 8060 Leucine, 8078 Infrared Absorption, Test A and Identification Related Compounds Tests General, Sodium, Ephedrine Hydrochloride, 8061 Levetiracetam, 8079 Infrared Absorption, Test A Limit of Levetiracetam R-Enantiomer, Limit of Chloride and Sulfate, Sulfate and Organic Levetiracetam Related Compound B, and Or- Impurities ganic Impurities Levothyroxine Sodium, 8081 Melting Range or Temperature (deleted) Identification Tests General, Sodium, Losartan Potassium Tablets, 8083 Etidronate Disodium, 8062 Lufenuron (new), 8086 Memantine Hydrochloride Tablets, 8087 Exemestane (new), 8064 Fluorometholone, 8065 and Thin-Layer Chromatography, Test Limit of Memantine Lactose Adduct and Or- C (deleted) ganic Impurities Mesna, 8090 (added) Identification Tests General, Sodium, Optical Rotation, Specific Rotation Limit of Sulfate and
7628 Annotated List First Supplement to USP 39 NF 34 Paroxetine Extended-Release Tablets, 8121 ph Metformin Hydrochloride Extended-Release Tab- lets, 8092 Methylprednisolone Sodium Succinate, 8100 Penicillin G Potassium, 8125 and (added) Minocycline Hydrochloride Extended-Release Tab- lets, 8101 Sterility Tests Penicillin V Potassium, 8126 Minoxidil Topical Solution, 8104 and (added) (added) Limit of Phenoxyacetic Acid Naphazoline Hydrochloride, 8105 Perindopril Erbumine (new), 8127 Perindopril Erbumine Tablets (new), 8130 Piperacillin and Tazobactam for Injection, 8132, Procedure 3 and Organic Impurities, Procedure 4 Orphenadrine Citrate, 8107 Quetiapine Tablets, 8139 and Identification Tests General, Cit- Infrared Absorption, Test A rate, (added) Rabeprazole Sodium (new), 8142 Rimexolone Ophthalmic Suspension, 8143, Procedure 1, Organic Im- purities, Procedure 2 (added) and Isomer Viscosity Capillary Methods or Viscosity Ro- Content tational Methods (deleted) and Viscosity Rotational Methods (added) Melting Range or Temperature (deleted) and Risedronate Sodium, 8144 Clarity and Color of Solution (deleted) Identification Tests General, Sodium, Packaging and Storage (added), Labeling Sildenafil Tablets (new), 8146 (added) and Sodium Bicarbonate, 8147 Oxcarbazepine Tablets, 8110 Limit of Ammonia Sodium Chloride And Dextrose Tablets (deleted), 8151 Oxtriphylline Delayed-Release Tablets (deleted), Sodium Thiosulfate, 8151 8112 Oxycodone Hydrochloride, 8113 Test A; Identification Tests General, Sodium, ; and (deleted) (added) Limit of Alcohol (added) and Organic (added) Impurities Sodium Thiosulfate Injection, 8152 Procedure, Test A; Identification Tests Gen- eral, Sodium, ; and Identification Oxymetazoline Hydrochloride, 8116 Tests General, Thiosulfate, Somatropin, 8153 (added) Chromatographic Purity Somatropin for Injection, 8155 Palonosetron Hydrochloride (new), 8118 Paricalcitol, 8120 Chromatographic Purity Succinylcholine Chloride, 8156
First Supplement to USP 39 NF 34 Annotated List 7629 (added) OTHER COMPONENTS (deleted) and Limit of Choline Tramadol Hydrochloride Extended-Release Tablets, 8170 Sterility Tests (deleted) and Bacterial Endo- toxins Test (deleted) Packaging and Storage, Labeling (deleted) and Succinylcholine Chloride for Injection (deleted), 8158 Triamcinolone Acetonide Nasal Spray (new), 8173 Sulindac, 8159 Triprolidine Hydrochloride, 8177 (added) Sulindac Tablets, 8160 Valproic Acid Capsules, 8178 (added) Vardenafil Hydrochloride (new), 8179 Sumatriptan Tablets, 8162 Warfarin Sodium, 8180 Infrared Absorption, Test A and Temozolomide, 8164 Procedure Absorbance in Alkaline Solution Zolmitriptan (new), 8183 Zolmitriptan Tablets (new), 8185 Zolpidem Tartrate Tablets, 8187 Teniposide (new), 8165 Teniposide Injection (new), 8167 Timolol Maleate Tablets, 8268 Zolpidem Tartrate Extended-Release Tablets, 8189 Test A and (added)