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PF 44(4) Table of Contents Publish date: July 16, 2018

PROPOSED IRA

Proposed Interim Revision Announcements

USP MONOGRAPHS

Insulin (1-Jan-2019)
Insulin Injection (1-Jan-2019)
Insulin Aspart Injection (1-Jan-2019)
Human Insulin Isophane Suspension and Human Insulin Injection (1-Jan-2019)
Isophane Insulin Suspension (1-Jan-2019)
Isophane Insulin Human Suspension (1-Jan-2019)
Insulin Lispro (1-Jan-2019)
Insulin Lispro Injection (1-Jan-2019)
Insulin Zinc Suspension (1-Jan-2019)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<203> HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY PROCEDURE FOR IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN (USP42-NF37 2S)
<591> ZINC DETERMINATION (USP42-NF37 2S) 
<607> PHARMACEUTICAL FOAMS-PRODUCT QUALITY TESTS [NEW] (USP42-NF37 2S) 
<659> PACKAGING AND STORAGE REQUIREMENTS (USP42-NF37 2S) 
<861> SUTURES-DIAMETER (USP42-NF37 2S) 
<871> SUTURES-NEEDLE ATTACHMENT (USP42-NF37 2S) 
<881> TENSILE STRENGTH (USP42-NF37 2S) 
<1079> GOOD STORAGE AND DISTRIBUTION PRACTICES FOR DRUG PRODUCTS (USP42-NF37 2S) 
<1085> GUIDELINES ON THE ENDOTOXINS TEST [NEW] (USP42-NF37 2S) 
<1430> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-GENERAL [NEW] (USP42-NF37 2S) 
<1430.1> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-STATIC LIGHT SCATTERING [NEW] (USP42-NF37 2S) 
<1430.2> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-LIGHT DIFFRACTION MEASUREMENTS OF PARTICLE SIZE [NEW] (USP42-NF37 2S) 
<1430.3> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-DYNAMIC LIGHT SCATTERING [NEW] (USP42-NF37 2S) 
<1430.4> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-ELECTROPHORETIC LIGHT SCATTERING (DETERMINATION OF ZETA POTENTIAL) [NEW] (USP42-NF37 2S) 
<1430.5> ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA-SMALL-ANGLE X-RAY SCATTERING AND SMALL-ANGLE NEUTRON SCATTERING [NEW] (USP42-NF37 2S) 
<1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS-CHARACTERIZATION TESTS (USP42-NF37 2S) 
<2091> WEIGHT VARIATION OF DIETARY SUPPLEMENTS (USP42-NF37 2S)

REAGENTS, INDICATORS, AND SOLUTIONS

Reagent Specifications

Aqua Regia [NEW] (USP42-NF37 2S)
Triphenylphosphine Oxide [NEW] (USP42-NF37 2S)
Water, Ammonia-Free (USP42-NF37 2S)

Test Solutions

25% Tetrabutylammonium Hydroxide TS [NEW] (USP42-NF37 2S)

REFERENCE TABLES

Container Specifications

Container Specifications [NEW] (USP42-NF37 2S)

Description and Solubility

Description and Relative Solubility of USP and NF Articles (USP42-NF37 2S) 
Description and Solubility - N 
Description and Solubility - P 
Description and Solubility - R 
Description and Solubility - S

USP MONOGRAPHS

Acetaminophen Oral Solution (USP42-NF37 2S) 
Albuterol Tablets (USP42-NF37 2S) 
Aminobenzoate Potassium Tablets (USP42-NF37 2S) 
Aminobenzoate Sodium (USP42-NF37 2S) 
Amitriptyline Hydrochloride (USP42-NF37 2S) 
Bimatoprost [NEW] (USP42-NF37 2S) 
Bimatoprost Ophthalmic Solution [NEW] (USP42-NF37 2S) 
Brimonidine Tartrate Ophthalmic Solution [NEW] (USP42-NF37 2S) 
Bupropion Hydrochloride (USP42-NF37 2S) 
Bupropion Hydrochloride Tablets (USP42-NF37 2S) 
Bupropion Hydrochloride Extended-Release Tablets (USP42-NF37 2S) 
Carbidopa and Levodopa Tablets (USP42-NF37 2S) 
Clarithromycin Extended-Release Tablets (USP42-NF37 2S) 
Clindamycin Phosphate Vaginal Cream (USP42-NF37 2S) 
Clindamycin Phosphate Gel (USP42-NF37 2S) 
Clonidine Hydrochloride (USP42-NF37 2S) 
Clonidine Hydrochloride Injection [NEW] (USP42-NF37 2S) 
Doxycycline Compounded Oral Suspension, Veterinary (USP42-NF37 2S) 
Edetate Disodium Compounded Ophthalmic Solution [NEW] (USP42-NF37 2S) 
Erythromycin (USP42-NF37 2S) 
Erythromycin Ethylsuccinate (USP42-NF37 2S) 
Erythromycin Stearate (USP42-NF37 2S) 
Glycopyrrolate (USP42-NF37 2S) 
Indomethacin Extended-Release Capsules (USP42-NF37 2S) 
Insulin Human (USP42-NF37 2S) 
Iodinated I 131 Albumin Aggregated Injection (USP42-NF37 2S) 
Krypton Kr 81m (USP42-NF37 2S) 
Levobunolol Hydrochloride Ophthalmic Solution (USP42-NF37 2S) 
Lidocaine Hydrochloride Oral Topical Solution (USP42-NF37 2S) 
Lidocaine Hydrochloride Topical Solution (USP42-NF37 2S) 
Magaldrate Oral Suspension (USP42-NF37 2S) 
Magaldrate Tablets (USP42-NF37 2S) 
Magnesia Tablets (USP42-NF37 2S) 
Mazindol (USP42-NF37 2S) 
Mazindol Tablets (USP42-NF37 2S) 
Menadiol Sodium Diphosphate (USP42-NF37 2S) 
Menadiol Sodium Diphosphate Injection (USP42-NF37 2S) 
Menadiol Sodium Diphosphate Tablets (USP42-NF37 2S) 
Menadione Injection (USP42-NF37 2S) 
Meropenem (USP42-NF37 2S) 
Meropenem for Injection (USP42-NF37 2S) 
Methylbenzethonium Chloride Ointment (USP42-NF37 2S) 
Methylbenzethonium Chloride Topical Powder (USP42-NF37 2S) 
Methylprednisolone Sodium Succinate for Injection (USP42-NF37 2S) 
Monobenzone (USP42-NF37 2S) 
Monobenzone Cream (USP42-NF37 2S) 
Moricizine Hydrochloride (USP42-NF37 2S) 
Nicardipine Hydrochloride Injection (USP42-NF37 2S) 
Nitazoxanide [NEW] (USP42-NF37 2S) 
Omeprazole and Sodium Bicarbonate Capsules [NEW] (USP42-NF37 2S) 
Oxprenolol Hydrochloride Tablets (USP42-NF37 2S) 
Oxycodone Hydrochloride Oral Solution (USP42-NF37 2S) 
Piperacillin Sodium (USP42-NF37 2S) 
Pregabalin (USP42-NF37 2S) 
Pseudoephedrine Hydrochloride (USP42-NF37 2S) 
Pseudoephedrine Hydrochloride Extended-Release Tablets (USP42-NF37 2S) 
Quinapril Tablets (USP42-NF37 2S) 
Rifabutin (USP42-NF37 2S) 
Rifabutin Capsules (USP42-NF37 2S) 
Ropivacaine Hydrochloride (USP42-NF37 2S) 
Rufinamide Tablets (USP42-NF37 2S) 
Sodium Fluoride Gel (USP42-NF37 2S) 
Absorbable Surgical Suture (USP42-NF37 2S) 
Nonabsorbable Surgical Suture (USP42-NF37 2S) 
Tetracycline Hydrochloride Capsules (USP42-NF37 2S) 
Tizanidine Capsules [NEW] (USP42-NF37 2S) 
Triamterene and Hydrochlorothiazide Tablets (USP42-NF37 2S) 
Trifluridine (USP42-NF37 2S) 
Valproate Sodium Injection (USP42-NF37 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Ascorbic Acid Chewable Gels (USP42-NF37 2S) 
Cholecalciferol Chewable Gels (USP42-NF37 2S) 
Menaquinone-7 (USP42-NF37 2S) 
Menaquinone-7 Preparation (USP42-NF37 2S) 
Pyrroloquinoline Quinone Disodium [NEW] (USP42-NF37 2S)

EXCIPIENTS

Excipients (USP and NF), Listed By Category (USP42-NF37 2S)
Briefing 
Introduction 
Emollient 
Solvent 
Vehicle

STAGE 4 HARMONIZATION

Stage 2 Harmonization

STIMULI TO THE REVISION PROCESS

STIMULI TO THE REVISION PROCESS 
Modernization of Color Measurement Methods in the USP-NF 
The Application of Abbreviated Impactor Measurement and Efficient Data Analysis in the Lifecycle of an Orally-Inhaled Product: A Roadmap 
The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions: Proper and Improper Application