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PF 45(2) Table of Contents Publish date: March 1, 2019

PROPOSED IRA

Proposed Interim Revision Announcements

Atropine Sulfate Ophthalmic Solution (1-Sep-2019)

Levothyroxine Sodium (1-Sep-2019)

Morphine Sulfate Compounded Injection (1-Sep-2019)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<31> Volumetric Apparatus (1-Aug-2020)

<191> Identification Tests - General (1-Aug-2020)

<659> Packaging and Storage Requirements (1-Aug-2020)

<661> Plastic Packaging Systems and Their Materials of Construction (1-Aug-2020)

<661.1> Plastic Materials of Construction (1-Aug-2020)

<661.2> Plastic Packaging Systems for Pharmaceutical Use (1-Aug-2020)

<665> Plastic Materials, Components, and Systems Used in The Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products (1-Aug-2020)

<791> pH (1-Aug-2020)

<841> Specific Gravity (1-Aug-2020)

<858> Raman Spectroscopy [NEW] (1-Aug-2020)

<1102> Immunological Test Methods - General Considerations (1-Aug-2020)

<1120> Raman Spectroscopy (1-Aug-2020)

<1603> Good Cascade Impactor Practices [NEW] (1-Aug-2020)

<1604> Data Interpretation of Aerodynamic Particle Size Distribution Measurements for Orally Inhaled Products [NEW] (1-Aug-2020)

<1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction With Respect to Their User Safety Impact (1-Aug-2020)

<1665> Characterization of Plastic Materials, Components, and Systems Used In The Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products (1-Aug-2020)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Atropic Acid [NEW] (1-Aug-2020)

Copper-EDTA Complex Solution [NEW] (1-Aug-2020)

Cupric Sulfate (1-Aug-2020)

Esomeprazole Magnesium Dihydrate [NEW] (1-Aug-2020)

Methylbenzothiazolone Hydrazone Hydrochloride (1-Aug-2020)

Silicone Oil [NEW] (1-Aug-2020)

Zinc Sulfate Heptahydrate (1-Aug-2020)

Test Solutions

0.1 M Ammonium Hydroxide TS [NEW] (1-Aug-2020)

Volumetric Solutions

Volumetric Solutions Introduction (1-Aug-2020)

2 N Acetic Acid VS (1-Aug-2020)

0.1 N Ammonium Thiocyanate VS (1-Aug-2020)

0.05 M Barium Perchlorate VS (1-Aug-2020)

Benzethonium Chloride, Two Hundred Fiftieth-Molar (0.004 M) (1-Aug-2020)

0.01 M Bismuth Nitrate VS (1-Aug-2020)

0.1 N Bromine VS (1-Aug-2020)

0.05 N Ceric Ammonium Nitrate VS (1-Aug-2020)

0.1 N Ceric Sulfate VS (1-Aug-2020)

0.1 N Cupric Nitrate VS (1-Aug-2020)

0.1 N Titanium Trichloride VS (1-Aug-2020)

Chromatographic Columns

L106 [NEW] (1-Aug-2020)

REFERENCE TABLES

Container Specifications [NEW] (1-Aug-2020)

Description and Solubility (1-Aug-2020)

USP MONOGRAPHS

Acebutolol Hydrochloride (1-Aug-2020)

Ammonium Chloride Delayed-Release Tablets (1-Aug-2020)

Amphotericin B Cream (1-Aug-2020)

Amphotericin B Lotion (1-Aug-2020)

Amphotericin B Ointment (1-Aug-2020)

Ampicillin and Probenecid for Oral Suspension (1-Aug-2020)

Anileridine (1-Aug-2020)

Anileridine Injection (1-Aug-2020)

Anileridine Hydrochloride (1-Aug-2020)

Anileridine Hydrochloride Tablets (1-Aug-2020)

Antimony Sodium Tartrate (1-Aug-2020)

Atomoxetine Hydrochloride (1-Aug-2020)

Avobenzone (1-Aug-2020)

Betaxolol Hydrochloride (1-Aug-2020)

Bisoprolol Fumarate and Hydrochlorothiazide Tablets (1-Aug-2020)

Carbachol (1-Aug-2020)

Cefdinir for Oral Suspension (1-Aug-2020)

Chloramphenicol Oral Solution (1-Aug-2020)

Cilostazol Tablets (1-Aug-2020)

Clomiphene Citrate Tablets (1-Aug-2020)

Dexmedetomidine Hydrochloride (1-Aug-2020)

Diazepam (1-Aug-2020)

Diazepam Injection (1-Aug-2020)

Diazepam Tablets (1-Aug-2020)

Dibucaine Hydrochloride (1-Aug-2020)

Dobutamine Hydrochloride (1-Aug-2020)

Doxepin Hydrochloride (1-Aug-2020)

Drometrizole Trisiloxane [NEW] (1-Aug-2020)

Etoposide Phosphate [NEW] (1-Aug-2020)

Etoposide Phosphate for Injection [NEW] (1-Aug-2020)

Flavoxate Hydrochloride (1-Aug-2020)

Granisetron Hydrochloride Injection (1-Aug-2020)

Granisetron Hydrochloride Tablets (1-Aug-2020)

Haloperidol Decanoate (1-Aug-2020)

Inulin in Sodium Chloride Injection (1-Aug-2020)

Isometheptene Mucate (1-Aug-2020)

Isometheptene Mucate, Dichloralphenazone, and Acetaminophen Capsules (1-Aug-2020)

Lactase (1-Aug-2020)

Lisinopril Tablets (1-Aug-2020)

Lithium Carbonate (1-Aug-2020)

Lithium Hydroxide (1-Aug-2020)

Magnesium Sulfate (1-Aug-2020)

Maprotiline Hydrochloride (1-Aug-2020)

Methylphenidate Hydrochloride (1-Aug-2020)

Moexipril Hydrochloride and Hydrochlorothiazide Tablets (1-Aug-2020)

Naratriptan Hydrochloride (1-Aug-2020)

Nortriptyline Hydrochloride (1-Aug-2020)

Nortriptyline Hydrochloride Capsules (1-Aug-2020)

Nortriptyline Hydrochloride Oral Solution (1-Aug-2020)

Oxiconazole Nitrate [NEW] (1-Aug-2020)

Oxiconazole Nitrate Cream [NEW] (1-Aug-2020)

Oxiconazole Nitrate Lotion [NEW] (1-Aug-2020)

Phenoxybenzamine Hydrochloride (1-Aug-2020)

Phenoxybenzamine Hydrochloride Capsules (1-Aug-2020)

Potassium Bicarbonate (1-Aug-2020)

Potassium Bicarbonate Effervescent Tablets for Oral Solution (1-Aug-2020)

Potassium Chloride in Lactated Ringer's and Dextrose Injection (1-Aug-2020)

Primaquine Phosphate Tablets (1-Aug-2020)

Proparacaine Hydrochloride (1-Aug-2020)

Propylthiouracil Compounded Oral Suspension (1-Aug-2020)

Protriptyline Hydrochloride (1-Aug-2020)

Ringer's Injection (1-Aug-2020)

Lactated Ringer's Injection (1-Aug-2020)

Lactated Ringer's and Dextrose Injection (1-Aug-2020)

Half-Strength Lactated Ringer's and Dextrose Injection (1-Aug-2020)

Modified Lactated Ringer's and Dextrose Injection (1-Aug-2020)

Rivaroxaban [NEW] (1-Aug-2020)

Rivaroxaban Tablets [NEW] (1-Aug-2020)

Ropinirole Hydrochloride (1-Aug-2020)

Selegiline Hydrochloride Capsules (1-Aug-2020)

Sertraline Hydrochloride (1-Aug-2020)

Sevelamer Carbonate [NEW] (1-Aug-2020)

Sulfasalazine (1-Aug-2020)

Thioridazine Hydrochloride (1-Aug-2020)

Tizanidine Hydrochloride (1-Aug-2020)

Zidovudine Oral Solution (1-Aug-2020)

DIETARY SUPPLEMENT MONOGRAPHS

Citicoline [NEW] (1-Aug-2020)

Saw Palmetto Capsules (1-Aug-2020)

Saw Palmetto Extract (1-Aug-2020)

Oil- and Water-Soluble Vitamins with Minerals Chewable Gels [NEW] (1-Aug-2020)

STAGE 2 HARMONIZATION

Stage 2 Harmonization

STIMULI TO THE REVISION PROCESS

Stimuli to the Revision Process

Monographs for Non-Radioactive Kits for the Preparation of Radiopharmaceuticals

Reusable Passive Thermal Packaging System: Best Practice Guideline