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PF 46(5) Table of Contents Publish date: [September 1, 2020]

Proposed Interim Revision Announcements

Desmopressin Acetate 1-MAR-2021

Triamcinolone Acetonide Nasal Spray 1-MAR-2021

Ribose 1-MAR-2021

In-Process Revision

In-Process Revision Introduction

General Chapters

<665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products USPNF 2022 ISSUE 1

<1072> Disinfectants and Antiseptics USPNF 2022 ISSUE 1

<1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test - Photometric and Fluorometric Methods Using Recombinantly Derived Reagents [NEW] USPNF 2022 ISSUE 1

<1220> Analytical Procedure Life Cycle [NEW] USPNF 2022 ISSUE 1

<1223.1> Validation of Alternative Methods to Antibiotic Microbial Assays USPNF 2022 ISSUE 1

<1469> Nitrosamine Impurities [NEW] USPNF 2022 ISSUE 1

<1604> Presentation of Aerodynamic Particle Size Distribution Measurement Data USPNF 2022 ISSUE 1

<1665> Characterization of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products USPNF 2022 ISSUE 1

Reagents, Indicators, and Solutions

Reagent Specifications

Alpha-(2-(methylamino)ethyl)benzyl Alcohol USPNF 2022 ISSUE 1

Chromatographic Columns

L124 [NEW] USPNF 2022 ISSUE 1

Reference Tables

Description and Solubility USPNF 2022 ISSUE 1

USP Monographs

Acetazolamide USPNF 2022 ISSUE 1

Acetazolamide Extended-Release Capsules [NEW] USPNF 2022 ISSUE 1

Acetylcysteine and Isoproterenol Hydrochloride Inhalation Solution USPNF 2022 ISSUE 1

Aloe Vera Leaf Juice Concentrate [NEW] USPNF 2022 ISSUE 1

Alprostadil USPNF 2022 ISSUE 1

Aprotinin USPNF 2022 ISSUE 1

Aprotinin Injection USPNF 2022 ISSUE 1

Armodafinil [NEW] USPNF 2022 ISSUE 1

Armodafinil Tablets [NEW] USPNF 2022 ISSUE 1

Benzethonium Chloride Topical Solution USPNF 2022 ISSUE 1

Calcium Acetate Capsules USPNF 2022 ISSUE 1

Calcium Acetate Oral Solution [NEW] USPNF 2022 ISSUE 1

Calcium Acetate Tablets USPNF 2022 ISSUE 1

Carboplatin Injection [NEW] USPNF 2022 ISSUE 1

Carteolol Hydrochloride USPNF 2022 ISSUE 1

Carteolol Hydrochloride Ophthalmic Solution USPNF 2022 ISSUE 1

Cefazolin In Dextrose Injection USPNF 2022 ISSUE 1

Chlorpropamide USPNF 2022 ISSUE 1

Chlorpropamide Tablets USPNF 2022 ISSUE 1

Cisplatin Injection [NEW] USPNF 2022 ISSUE 1

Dichlorphenamide USPNF 2022 ISSUE 1

Diltiazem Hydrochloride Compounded Cream [NEW] USPNF 2022 ISSUE 1

Dutasteride USPNF 2022 ISSUE 1

Dutasteride Capsules [NEW] USPNF 2022 ISSUE 1

Dutasteride and Tamsulosin Hydrochloride Capsules [NEW] USPNF 2022 ISSUE 1

Enflurane USPNF 2022 ISSUE 1

Ensulizole USPNF 2022 ISSUE 1

Flucytosine USPNF 2022 ISSUE 1

Flucytosine Capsules USPNF 2022 ISSUE 1

Fluorescein USPNF 2022 ISSUE 1

Fluoxetine Capsules USPNF 2022 ISSUE 1

Fluoxetine Delayed-Release Capsules USPNF 2022 ISSUE 1

Fluoxetine Oral Solution USPNF 2022 ISSUE 1

Fluoxetine Tablets USPNF 2022 ISSUE 1

Fluoxetine Hydrochloride USPNF 2022 ISSUE 1

Fructose USPNF 2022 ISSUE 1

Galantamine Hydrobromide USPNF 2022 ISSUE 1

Guaifenesin Oral Solution USPNF 2022 ISSUE 1

Hexylresorcinol USPNF 2022 ISSUE 1

Insulin Glargine USPNF 2022 ISSUE 1

Insulin Glargine Injection USPNF 2022 ISSUE 1

Isosorbide Dinitrate Chewable Tablets USPNF 2022 ISSUE 1

Isosorbide Dinitrate Sublingual Tablets USPNF 2022 ISSUE 1

Lamivudine and Zidovudine Tablets USPNF 2022 ISSUE 1

Malathion USPNF 2022 ISSUE 1

Methenamine Tablets USPNF 2022 ISSUE 1

Methimazole USPNF 2022 ISSUE 1

Methyclothiazide USPNF 2022 ISSUE 1

Methyclothiazide Tablets USPNF 2022 ISSUE 1

Micafungin for Injection [NEW] USPNF 2022 ISSUE 1

Micafungin Sodium [NEW] USPNF 2022 ISSUE 1

Nicotine USPNF 2022 ISSUE 1

Nitrofurazone Topical Solution USPNF 2022 ISSUE 1

Oxaprozin USPNF 2022 ISSUE 1

Palonosetron Hydrochloride USPNF 2022 ISSUE 1

Palonosetron Injection [NEW] USPNF 2022 ISSUE 1

Pamidronate Disodium USPNF 2022 ISSUE 1

Papaverine Hydrochloride Tablets USPNF 2022 ISSUE 1

Penicillin G Benzathine Oral Suspension USPNF 2022 ISSUE 1

Penicillin G Benzathine Tablets USPNF 2022 ISSUE 1

Phendimetrazine Tartrate Capsules USPNF 2022 ISSUE 1

Phenytoin Sodium Injection USPNF 2022 ISSUE 1

Piperazine Adipate USPNF 2022 ISSUE 1

Potassium Gluconate and Potassium Chloride Oral Solution USPNF 2022 ISSUE 1

Potassium Gluconate and Potassium Chloride for Oral Solution USPNF 2022 ISSUE 1

Potassium Gluconate and Potassium Citrate Oral Solution USPNF 2022 ISSUE 1

Potassium Gluconate, Potassium Citrate, and Ammonium Chloride Oral Solution USPNF 2022 ISSUE 1

Procyclidine Hydrochloride USPNF 2022 ISSUE 1

Procyclidine Hydrochloride Tablets USPNF 2022 ISSUE 1

Progesterone Injectable Suspension USPNF 2022 ISSUE 1

Propylthiouracil USPNF 2022 ISSUE 1

Roflumilast USPNF 2022 ISSUE 1

Roflumilast Tablets [NEW] USPNF 2022 ISSUE 1

Roxarsone USPNF 2022 ISSUE 1

Saquinavir Mesylate Tablets [NEW] USPNF 2022 ISSUE 1

Sodium Chloride Ophthalmic Ointment USPNF 2022 ISSUE 1

Sodium Gluconate USPNF 2022 ISSUE 1

Sodium Nitrite USPNF 2022 ISSUE 1

Sodium Nitrite Injection USPNF 2022 ISSUE 1

Sodium Sulfate Injection USPNF 2022 ISSUE 1

Streptomycin Injection USPNF 2022 ISSUE 1

Thiabendazole Chewable Tablets USPNF 2022 ISSUE 1

Tiagabine Hydrochloride Tablets [NEW] USPNF 2022 ISSUE 1

Tobramycin and Fluorometholone Acetate Ophthalmic Suspension USPNF 2022 ISSUE 1

Tolmetin Sodium USPNF 2022 ISSUE 1

Tolmetin Sodium Capsules USPNF 2022 ISSUE 1

Tolmetin Sodium Tablets USPNF 2022 ISSUE 1

Trikates Oral Solution USPNF 2022 ISSUE 1

Trimeprazine Oral Solution USPNF 2022 ISSUE 1

Ulipristal Acetate [NEW] USPNF 2022 ISSUE 1

Ulipristal Acetate Tablets [NEW] USPNF 2022 ISSUE 1

Dietary Supplements

Ajowan Fruit [NEW] USPNF 2022 ISSUE 1

Ajowan Fruit Oil [NEW] USPNF 2022 ISSUE 1

Ajowan Fruit Powder [NEW] USPNF 2022 ISSUE 1

Aloe Vera Leaf Dry Juice [NEW] USPNF 2022 ISSUE 1

Aloe Vera Leaf Juice [NEW] USPNF 2022 ISSUE 1

Bacillus Clausii [NEW] USPNF 2022 ISSUE 1

Black Cumin Seed Thymoquinone Oil [NEW] USPNF 2022 ISSUE 1

Siler Root [NEW] USPNF 2022 ISSUE 1

Siler Root Dry Extract [NEW] USPNF 2022 ISSUE 1

Siler Root Powder [NEW] USPNF 2022 ISSUE 1

NF Monographs

Anhydrous Lactose USPNF 2022 ISSUE 1

Lactose Monohydrate USPNF 2022 ISSUE 1

Stage 2 Harmonization

Stage 2 Harmonization Introduction

Carboxymethylcellulose Sodium

Stimuli to The Revision Process

USP Responses to Comments on Stimuli Article: "The Complexity of Setting Compendial Specifications for Excipient Composition and Impurities" [NEW]

Modernization of Asbestos Testing in USP Talc - Part 2 [NEW]

Revisions to the USP-NF Lactose Monographs - Focusing on Inhalation and Injection Grades [NEW]