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PF 46(4) Table of Contents Publish date: [July 1, 2020]

Proposed Interim Revision Announcements

Proposed Interim Revision Announcements Introduction

Filgrastim (1-Jan-2021)

In-Process Revision

In-Process Revision Introduction

General Chapters

<1> Injections and Implanted Drug Products (Parentals) - Product Quality Tests (USPNF 2021 ISSUE 3)

<426> Histamine Test Method [NEW] (USPNF 2021 ISSUE 3)

<831> Refractive Index (USPNF 2021 ISSUE 3)

<1010> Analytical Data - Interpretation and Treatment (USPNF 2021 ISSUE 3)

<1032> Design and Development of Biological Assays (USPNF 2021 ISSUE 3)

Reagents, Indicators, and Solutions

Reagent Specifications

Acrylamide [NEW] (USPNF 2021 ISSUE 3)

Ampholytes [NEW] (USPNF 2021 ISSUE 3)

Bisacrylamide [NEW] (USPNF 2021 ISSUE 3)

Endoproteinase Glu-C [NEW] (USPNF 2021 ISSUE 3)

Glycine [NEW] (USPNF 2021 ISSUE 3)

Granulocyte Colony Stimulating Factor [NEW] (USPNF 2021 ISSUE 3)

Interleukin 3 [NEW] (USPNF 2021 ISSUE 3)

M-NFS-60 Cells [NEW] (USPNF 2021 ISSUE 3)

Malathion Impurity B [NEW] (USPNF 2021 ISSUE 3)

Polyacrylamide [NEW] (USPNF 2021 ISSUE 3)

RPMI 1640 Medium [NEW] (USPNF 2021 ISSUE 3)

Deuterated Sodium 3-Trimethylsilylpropionate [NEW] (USPNF 2021 ISSUE 3)

Test Solutions

pH 7.4 Phosphate Buffered Saline TS [NEW] (USPNF 2021 ISSUE 3)

Volumetric Solutions

0.1 N Ceric Ammonium Sulfate VS [NEW] (USPNF 2021 ISSUE 3)

0.01 N Ceric Ammonium Sulfate VS [NEW] (USPNF 2021 ISSUE 3)

Reference Tables

Description and Solubility [NEW] (USPNF 2021 ISSUE 3)

Alcoholometric Table (USPNF 2021 ISSUE 3)

USP Monographs

Acyclovir Injection [NEW] (USPNF 2021 ISSUE 3)

Alcohol (USPNF 2021 ISSUE 3)

Dehydrated Alcohol (USPNF 2021 ISSUE 3)

Altretamine (USPNF 2021 ISSUE 3)

Altretamine Capsules (USPNF 2021 ISSUE 3)

Artemether [NEW] (USPNF 2021 ISSUE 3)

Bendroflumethiazide (USPNF 2021 ISSUE 3)

Carbidopa Tablets [NEW] (USPNF 2021 ISSUE 3)

Choline C 11 Injection [NEW] (USPNF 2021 ISSUE 3)

Cetirizine Hydrochloride Chewable Tablets [NEW] (USPNF 2021 ISSUE 3)

Chloroprocaine Hydrochloride Injection (USPNF 2021 ISSUE 3)

Cisplatin for Injection (USPNF 2021 ISSUE 3)

Cyclosporine (USPNF 2021 ISSUE 3)

Danazol (USPNF 2021 ISSUE 3)

Danazol Capsules (USPNF 2021 ISSUE 3)

Dapsone (USPNF 2021 ISSUE 3)

Demecarium Bromide Ophthalmic Solution (USPNF 2021 ISSUE 3)

Desoximetasone Topical Spray [NEW] (USPNF 2021 ISSUE 3)

Didanosine Tablets for Oral Suspension (USPNF 2021 ISSUE 3)

Diphenoxylate Hydrochloride (USPNF 2021 ISSUE 3)

Dorzolamide Hydrochloride Ophthalmic Solution (USPNF 2021 ISSUE 3)

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution (USPNF 2021 ISSUE 3)

Epitetracycline Hydrochloride (USPNF 2021 ISSUE 3)

Ergocalciferol Oral Solution (USPNF 2021 ISSUE 3)

Ergonovine Maleate Tablets (USPNF 2021 ISSUE 3)

Erythromycin Estolate (USPNF 2021 ISSUE 3)

Erythromycin Estolate for Oral Suspension (USPNF 2021 ISSUE 3)

Estrone Injectable Suspension (USPNF 2021 ISSUE 3)

Ferrous Fumarate Tablets (USPNF 2021 ISSUE 3)

Formoterol Fumarate (USPNF 2021 ISSUE 3)

Fosamprenavir Calcium [NEW] (USPNF 2021 ISSUE 3)

Fosamprenavir Calcium Tablets [NEW] (USPNF 2021 ISSUE 3)

Fulvestrant Injection [NEW] (USPNF 2021 ISSUE 3)

Furosemide Oral Solution (USPNF 2021 ISSUE 3)

Gadoversetamide (USPNF 2021 ISSUE 3)

Gadoversetamide Injection (USPNF 2021 ISSUE 3)

Gemcitabine Injection [NEW] (USPNF 2021 ISSUE 3)

Glucagon (USPNF 2021 ISSUE 3)

Gluconolactone (USPNF 2021 ISSUE 3)

Glycopyrrolate Injection (USPNF 2021 ISSUE 3)

Hydrochlorothiazide (USPNF 2021 ISSUE 3)

Ibandronate Sodium [NEW] (USPNF 2021 ISSUE 3)

Ibandronate Sodium Injection [NEW] (USPNF 2021 ISSUE 3)

Ibandronate Sodium Tablets [NEW] (USPNF 2021 ISSUE 3)

Iohexol (USPNF 2021 ISSUE 3)

Lime (USPNF 2021 ISSUE 3)

Lindane Cream (USPNF 2021 ISSUE 3)

Mafenide Acetate (USPNF 2021 ISSUE 3)

Meclofenamate Sodium (USPNF 2021 ISSUE 3)

Meclofenamate Sodium Capsules (USPNF 2021 ISSUE 3)

Mesna Injection [NEW] (USPNF 2021 ISSUE 3)

Methacycline Hydrochloride Oral Suspension (USPNF 2021 ISSUE 3)

Methoxyflurane (USPNF 2021 ISSUE 3)

Methylphenidate Hydrochloride Tablets (USPNF 2021 ISSUE 3)

Mitotane (USPNF 2021 ISSUE 3)

Mitotane Tablets (USPNF 2021 ISSUE 3)

Naproxen Compounded Oral Suspension (USPNF 2021 ISSUE 3)

Neomycin and Polymyxin B Sulfates and Hydrocortisone Acetate Ophthalmic Suspension (USPNF 2021 ISSUE 3)

Norethindrone Acetate and Ethinyl Estradiol Tablets (USPNF 2021 ISSUE 3)

Nortriptyline Hydrochloride Oral Solution (USPNF 2021 ISSUE 3)

Olanzapine Orally Disintegrating Tablets (USPNF 2021 ISSUE 3)

Oxtriphylline (USPNF 2021 ISSUE 3)

Oxtriphylline Extended-Release Tablets (USPNF 2021 ISSUE 3)

Oxycodone Hydrochloride Extended-Release Tablets (USPNF 2021 ISSUE 3)

Penicillin G Procaine, Dihydrostreptomycin Sulfate, and Prednisolone Injectable Suspension (USPNF 2021 ISSUE 3)

Perindopril Erbumine (USPNF 2021 ISSUE 3)

Prednisolone Hemisuccinate (USPNF 2021 ISSUE 3)

Prednisolone Sodium Phosphate Compounded Oral Solution (USPNF 2021 ISSUE 3)

Prednisolone Sodium Succinate for Injection (USPNF 2021 ISSUE 3)

Procarbazine Hydrochloride (USPNF 2021 ISSUE 3)

Propofol Injectable Emulsion (USPNF 2021 ISSUE 3)

Quinidine Sulfate Capsules (USPNF 2021 ISSUE 3)

Racepinephrine (USPNF 2021 ISSUE 3)

Reserpine and Chlorothiazide Tablets (USPNF 2021 ISSUE 3)

Rifampin (USPNF 2021 ISSUE 3)

Rifampin Capsules (USPNF 2021 ISSUE 3)

Scopolamine Hydrobromide (USPNF 2021 ISSUE 3)

Invert Sugar Injection (USPNF 2021 ISSUE 3)

Sulfacetamide Sodium (USPNF 2021 ISSUE 3)

Sulfadiazine (USPNF 2021 ISSUE 3)

Sulfadiazine Sodium (USPNF 2021 ISSUE 3)

Sunitinib Malate [NEW] (USPNF 2021 ISSUE 3)

Thioguanine (USPNF 2021 ISSUE 3)

Ticarcillin and Clavulanic Acid for Injection (USPNF 2021 ISSUE 3)

Dietary Supplements

Annatto Seed Oil Tocotrienols (USPNF 2021 ISSUE 3)

Red Asian Ginseng Root and Rhizome [NEW] (USPNF 2021 ISSUE 3)

Red Asian Ginseng Root and Rhizome Powder [NEW] (USPNF 2021 ISSUE 3)

Bitter Orange Fruit Flavonoids Dry Extract (USPNF 2021 ISSUE 3)

Citrulline (USPNF 2021 ISSUE 3)

Pyrroloquinoline Quinone Disodium (USPNF 2021 ISSUE 3)

NF Monographs

White Wax (USPNF 2021 ISSUE 3)

Yellow Wax (USPNF 2021 ISSUE 3)

Stage 2 Harmonization

Stage 2 Harmonization Introduction

Sucrose

Stimuli to The Revision Process

<1174> Powder Flow - Current Characterization Practices [NEW]

A Life Cycle Approach to the Calibration and Qualification of Analytical Instruments and Systems to Establish "Fitness for Purpose" for Pharmacopeial Purposes [NEW]

USP's Approach for Future Revision of Biological Reactivity Chapters <87>, <88>, and <1031>