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PF 44(2) Table of Contents Publish date: April 30, 2018

PROPOSED IRA: Proposed Interim Revision Announcements

USP MONOGRAPHS

IN-PROCESS REVISION: In-Process Revision

GENERAL CHAPTERS <2> ORAL DRUG PRODUCTS-PRODUCT QUALITY TESTS (USP42-NF37 1S) <41> BALANCES (USP42-NF37 1S) <701> DISINTEGRATION (USP42-NF37 1S) <729> GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS (USP42-NF37 1S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications Octylamine [NEW] (USP42-NF37 1S) Poly(dimethylsiloxane-co-methylphenylsiloxane) [NEW] (USP42-NF37 1S) Silica Gel, Precoated Plates, with Fluorescence Indicator F254 [NEW] (USP42-NF37 1S) Sodium 1-Heptanesulfonate Monohydrate (USP42-NF37 1S) Tryptamine Hydrochloride [NEW] (USP42-NF37 1S)

Test Solutions 1 M Phosphoric Acid TS [NEW] (USP42-NF37 1S)

Volumetric Solutions 0.1 N Potassium Arsenite VS (USP42-NF37 1S) 0.1 N Sodium Hydroxide VS (USP42-NF37 1S)

Chromatographic Columns G50 [NEW] (USP42-NF37 1S) L87 (USP42-NF37 1S) L117 [NEW] (USP42-NF37 1S)

REFERENCE TABLES Container Specifications Container Specifications [NEW] (USP42-NF37)

Description and Solubility

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Description and Relative Solubility of USP and NF Articles (USP42-NF37 1S) Description and Solubility - A Description and Solubility - C Description and Solubility - F Description and Solubility - N Description and Solubility - S

USP MONOGRAPHS Allopurinol Compounded Oral Suspension (USP42-NF37 1S) (USP42-NF37 1S) Aminoglutethimide Tablets (USP42-NF37 1S) Aminosalicylate Sodium (USP42-NF37 1S) Aminosalicylate Sodium Tablets (USP42-NF37 1S) Aminosalicylic Acid Tablets (USP42-NF37 1S) and Olmesartan Medoxomil Tablets [NEW] (USP42-NF37 1S) for Injection (USP42-NF37 1S) Benazepril Hydrochloride Tablets (USP42-NF37 1S) Bivalirudin [NEW] (USP42-NF37 1S) Bivalirudin for Injection [NEW] (USP42-NF37 1S) Cefepime for Injection (USP42-NF37 1S) Chlorothiazide Sodium for Injection (USP42-NF37 1S) Cholecalciferol Capsules (USP42-NF37 1S) Injection (USP42-NF37 1S) Clindamycin Hydrochloride Capsules (USP42-NF37 1S) Clindamycin Hydrochloride Compounded Oral Solution [NEW] (USP42-NF37 1S) Clindamycin Hydrochloride Oral Solution (USP42-NF37 1S) Clindamycin Phosphate Topical Solution (USP42-NF37 1S) Clindamycin Phosphate Vaginal Inserts (USP42-NF37 1S) Clobetasol Propionate Ointment (USP42-NF37 1S) Dacarbazine (USP42-NF37 1S) Dacarbazine for Injection (USP42-NF37 1S) Desmopressin Acetate (USP42-NF37 1S) Desoximetasone (USP42-NF37 1S) (USP42-NF37 1S) Doxycycline Hyclate (USP42-NF37 1S) Ephedrine Hydrochloride (USP42-NF37 1S) Epoprostenol Sodium [NEW] (USP42-NF37 1S) Epoprostenol for Injection [NEW] (USP42-NF37 1S) Ergocalciferol Capsules (USP42-NF37 1S) Ergoloid Mesylates Sublingual Tablets (USP42-NF37 1S) Ergotamine Tartrate Sublingual Tablets (USP42-NF37 1S) Escitalopram Oral Solution (USP42-NF37 1S) Fosfomycin Tromethamine (USP42-NF37 1S) Glycopyrrolate Tablets (USP42-NF37 1S) Gonadorelin Acetate (USP42-NF37 1S) Hydroxychloroquine Sulfate (USP42-NF37 1S) Tablets for Oral Suspension (USP42-NF37 1S) Loracarbef Capsules (USP42-NF37 1S)

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Loracarbef for Oral Suspension (USP42-NF37 1S) Magnesium Carbonate (USP42-NF37 1S) Magnesium Trisilicate (USP42-NF37 1S) Manganese Chloride for Oral Solution (USP42-NF37 1S) Manganese Sulfate Injection (USP42-NF37 1S) Meclocycline Sulfosalicylate (USP42-NF37 1S) Meclocycline Sulfosalicylate Cream (USP42-NF37 1S) Mephenytoin (USP42-NF37 1S) Mephenytoin Tablets (USP42-NF37 1S) Meprednisone (USP42-NF37 1S) Meprobamate Oral Suspension (USP42-NF37 1S) Mesoridazine Besylate (USP42-NF37 1S) Mesoridazine Besylate Injection (USP42-NF37 1S) Mesoridazine Besylate Tablets (USP42-NF37 1S) Metaproterenol Sulfate Inhalation Solution (USP42-NF37 1S) Methacycline Hydrochloride Capsules (USP42-NF37 1S) Methdilazine Hydrochloride (USP42-NF37 1S) Methdilazine Hydrochloride Oral Solution (USP42-NF37 1S) Methdilazine Hydrochloride Tablets (USP42-NF37 1S) Methenamine Oral Solution (USP42-NF37 1S) Methenamine Mandelate for Oral Solution (USP42-NF37 1S) Methenamine Mandelate Oral Suspension (USP42-NF37 1S) Methenamine Mandelate Delayed-Release Tablets (USP42-NF37 1S) (USP42-NF37 1S) Minoxidil Tablets (USP42-NF37 1S) Naltrexone Hydrochloride Tablets (USP42-NF37 1S) Oxaprozin (USP42-NF37 1S) Phytonadione Compounded Oral Suspension [NEW] (USP42-NF37 1S) Prochlorperazine Maleate Tablets (USP42-NF37 1S) Pyridostigmine Oral Solution (USP42-NF37 1S) Pyridostigmine Bromide Extended-Release Tablets [NEW] (USP42-NF37 1S) Ropinirole Tablets (USP42-NF37 1S) Saccharin Calcium (USP42-NF37 1S) Saccharin Sodium (USP42-NF37 1S) Sulfate (USP42-NF37 1S) Sisomicin Sulfate Injection (USP42-NF37 1S) Sodium Phenylbutyrate Oral Powder [NEW] (USP42-NF37 1S) Sodium Phenylbutyrate Tablets [NEW] (USP42-NF37 1S) Sodium Thiosulfate (USP42-NF37 1S) Spironolactone (USP42-NF37 1S) Spironolactone Tablets (USP42-NF37 1S) Succinylcholine Chloride (USP42-NF37 1S) Testosterone Cypionate (USP42-NF37 1S) Testosterone Cypionate Injection (USP42-NF37 1S) Hydrochloride (USP42-NF37 1S) and Hydrochlorothiazide Capsules (USP42-NF37 1S) Vancomycin Hydrochloride Compounded Oral Solution [NEW] (USP42-NF37 1S) Vitamin A (USP42-NF37 1S)

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Vitamin A Capsules (USP42-NF37 1S) Vitamin A Oral Liquid Preparation (USP42-NF37 1S) Vitamin A Tablets (USP42-NF37 1S) Vitamin E (USP42-NF37 1S) Vitamin E Capsules (USP42-NF37 1S) Vitamin E Preparation (USP42-NF37 1S) Zolmitriptan (USP42-NF37 1S)

DIETARY SUPPLEMENT MONOGRAPHS Chinese Skullcap Root [NEW] (USP42-NF37 1S) Chinese Skullcap Root Powder [NEW] (USP42-NF37 1S) Chinese Skullcap Root Dry Extract [NEW] (USP42-NF37 1S) Chrysanthemum Flower [NEW] (USP42-NF37 1S) Chrysanthemum Flower Powder [NEW] (USP42-NF37 1S) Chrysanthemum Flower Dry Extract [NEW] (USP42-NF37 1S) Wild Chrysanthemum Flower [NEW] (USP42-NF37 1S) Wild Chrysanthemum Flower Powder [NEW] (USP42-NF37 1S) Wild Chrysanthemum Flower Dry Extract [NEW] (USP42-NF37 1S) Ginkgo Capsules (USP42-NF37 1S) Ginkgo Tablets (USP42-NF37 1S) Guarana Seed [NEW] (USP42-NF37 1S) Guarana Seed Powder [NEW] (USP42-NF37 1S) Guarana Seed Dry Extract [NEW] (USP42-NF37 1S) Conjugated Linoleic Acids-Triglycerides [NEW] (USP42-NF37 1S)

EXCIPIENTS USP and NF Excipients, Listed By Category [NEW] (USP42-NF37 1S) Briefing Introduction Flavors and Fragrance

NF MONOGRAPHS Anise Oil (USP42-NF37 1S) Potassium Sorbate (USP42-NF37 1S) Saccharin (USP42-NF37 1S) Sorbic Acid (USP42-NF37 1S) Star Anise Oil [NEW] (USP42-NF37 1S)

STAGE 4 HARMONIZATION: Stage 4 Harmonization

STIMULI TO THE REVISION PROCESS STIMULI TO THE REVISION PROCESS

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