New and Revised Content in USP 36  –NF 31

through the First Supplement

4 New & Revised General Chapters

‹1›  Injections
‹17› Prescription Container Labeling
‹87› Biological Reactivity Tests, In Vitro
‹88› Biological Reactivity Tests, In Vivo
‹208› Anti-factor XA and Anti-factor IIA Assays
for Unfractionated and Low Molecular
Weight Heparins
‹467› Residual Solvents
‹643› Total Organic Carbon
‹645› Water Conductivity
‹681› Repackaging into Single-Unit Containers
and Unit-Dose Containers for Nonsterile
Solid and Liquid Dosage Forms
‹761› Nuclear Magnetic Resonance Spectroscopy
‹788› Particulate Matter in Injections
‹1197› Good Distribution Practices for Bulk
‹841› Specific Gravity
‹921› Water Determination
‹1031› The Biocompatibility of Materials
Used In Drug Containers, Medical Devices,
and Implants
‹1051› Cleaning Glass Apparatus
‹1106› Immunogenicity Assays—Design and
Validation of Immunoassays to Detect Anti-
Drug Antibodies
‹1118› Monitoring Devices—Time, Temperature,
and Humidity
‹1136› Packaging—Unit of Use
‹1146› Packaging Practice—Repackaging
a Single Solid Oral Drug Product into a
Unit-Dose Container
Pharmaceutical Excipients
‹1229› Sterilization of Compendial Articles
‹1229.1› Steam Sterilization by Direct Contact
‹1229.2› Steam Sterilization of Aqueous Liquids
‹1231› Water for Pharmaceutical Purposes
‹1724› Semi-Solid Drug Products—
Performance Tests
‹1761› Applications of Nuclear Magnetic
Resonance Spectroscopy
‹2021› Microbial Enumeration Tests—
Nutritional and Dietary Supplements
‹2023› Microbiological Attributes of Nonsterile
Nutritional and Dietary Supplements
‹2040› Disintegration and Dissolution of
Dietary Supplements
‹2232› Elemental Contaminants in Dietary
Supplements

4 New & Revised Monographs

Drugs & Dosage Forms Bupropion Hydrochloride Haloperidol
Abacavir Tablets Calcitonin Salmon Hydrochloric Acid Injection
Acetaminophen Calcium Acetate Irinotecan Hydrochloride Injection
Adapalene Cefprozil Isophane Insulin Human Suspension
Adenosine Ciprofloxacin Extended-Release Tablets Isophane Insulin Suspension
Adenosine Injection Chloroquine Phosphate Oral Suspension Isradipine Oral Suspension
Alfuzosin Hydrochloride Clarithromycin Kanamycin Sulfate
Alfuzosin Hydrochloride Extended- Clarithromycin for Oral Suspension Ketorolac Tromethamine Tablets
Release Tablets Clarithromycin Extended-Release Tablets Latanoprost
Alprazolam Orally Disintregrating Tablets Clotrimazole Lozenges Levalbuterol Hydrochloride
Amikacin Clotrimazole Topical Solution Levalbuterol Inhalation Solution
Amikacin Sulfate Clotrimazole Vaginal Inserts Levodopa
Amikacin Sulfate Injection Codeine Phosphate Oral Solution Levodopa Capsules
Amiodarone Hydrochloride Oral Suspension Cyclizine Hydrochloride Levodopa Tablets
Amiloride Hydrochloride Tablets Cyclizine Hydrochloride Tablets Levothyroxine Sodium
Amitriptyline Hydrochloride Dapsone Lisinopril Oral Suspension
Amitriptyline Hydrochloride Injection Dapsone Oral Suspension Lithium Oral Solution
Amlodipine Oral Suspension Didanosine Delayed-Release Capsules Lopinavir
Amlodipine and Benazepril Hydrochloride Dinoprostone Lopinavir and Ritonavir Tablets
Capsules
Diphenhydramine Citrate and Ibuprofen Tablets Lorazepam Oral Concentrate
Ammonium Alum
Diphenhydramine Hydrochloride Losartan Potassium Tablets
Amodiaquine Hydrochloride Tablets
Divalproex Sodium Extended-Release Tablets Maprotiline Hydrochloride
Amoxapine Tablets
Docetaxel Menotropins
Amoxicillin and Clavulanic Acid Extended-
Docetaxel Injection Menotropins for Injection
Release Tablets
Dorzolamide Hydrochloride Ophthalmic Meprobamate
Ampicillin
Solution Meprobamate Tablets
Antipyrine
Doxycycline Hyclate Delayed-Release Tablets Metacresol
Aripiprazole
Doxycycline Tablets Metaformin Hydrochloride Extended-
Atomoxetine Hydrochloride
Enalapril Maleate Oral Suspension Release Tablets
Atropine Sulfate
Escitalopram Oxalate Methacholine Chloride
Atropine Sulfate Injection
Estazolam Methenamine Mandelate Delayed-Release
Baclofen Tablets
Estradiol Injectable Suspension
Baclofen Tablets Minoxidil Tablets
Estradiol Pellets
Benzethonium Chloride Concentrate Mirtazapine
Fluconazole for Oral Suspension
Benzethonium Chloride Topical Solution Mirtazapine Tablets
Galantamine Hydrobromide
Benzoyl Peroxide Lotion Mitomycin
Gemfibrozil
Betaxolol Hydrochloride New & Revised Monographs continue on Page 2
Gentamicin Sulfate

USPNF531W _ 2012-12 December 2012 – Page 1

 New and Revised Content in USP 36  –NF 31
through the First Supplement

Drugs & Dosage Forms (cont.) Spironolactone Oral Suspension Maltitol

Mitomycin for Injection Sulfasalazine Delayed-Release Tablets Maltose
Mitotane Sterile Purified Water Methyl Salicylate
Mycophenolate Mofetil Sterile Water for Inhalation Myristic Acid
Nicardipine Hydrochloride Sterile Water for Injection Octoxynol 9
Nortriptyline Hydrochloride Sterile Water for Irrigation Oleic Acid
Olanzapine Tacrolimus Oral Suspension Potassium Benzoate
Olanzapine Tablets Tadalafil Povidone
Omeprazole Oral Suspension Tadalafil Tablets Propane
Oxaliplatin Temazepam Propanediol
Oxcarbazepine Thioridazine Hydrochloride Tablets Sodium Benzoate
Paricalcitol Tramadol Hydrochloride and Acetaminophen Sucrose
Pentoxifylline Oral Suspension Oral Suspension
Phenobarbital Oral Suspension Tramadol Hydrochloride Oral Suspension Dietary Supplements
Potassium Iodide Delayed-Release Tablets Triacetin Black Pepper
Potassium Iodide Oral Solution Trospium Chloride Tablets Powdered Black Pepper
Potassium Iodide Tablets Ursodiol Oral Suspension Powdered Black Pepper Extract
Praziquantel Valacyclovir Oral Suspension Calcium Pantothenate Tablets
Propylthiouracil Oral Suspension Valacyclovir Tablets Gymnema
Pyrazinamide Oral Suspension Valproate Sodium Injection Native Gymnema Extract
Pyrimethamine Oral Suspension Valproic Acid Powdered Gymnema
Quinapril and Hydrochlorothiazide Tablets Valproic Acid Capsules Purified Gymnema Extract
Quinine Sulfate Capsules Valproic Acid Oral Solution Iron, Carbonyl
Quinine Sulfate Tablets Vigabatrin Levocarnitine Tablets
Raloxifene Hydrochloride Melatonin Tablets
Raloxifene Hydrochloride Tablets Excipients N-Acetyltyrosine
Ribavirin Capsules Ammonium Glycyrrhizate Oil-Soluble Vitamins Oral Solution
Rifabutin Oral Suspension Benzaldehyde Oil-Soluble Vitamins with Minerals Capsules
Rocuronium Bromide Butane Oil-Soluble Vitamins with Minerals
Rufinamide Butyl Palmitostearate Oral Solution
Rufinamide Tablets Butyl Stearate Oil-Soluble Vitamins with Minerals Tablets
Salicylic Acid Plaster Caprylic Acid Valerian
Selenious Acid Injection Caprylocaproyl Polyoxylglycerides Valerian Tablets
Sertraline Hydrochloride Oral Solution Cyclomethicone Powdered Valerian
Sildenafil Citrate Oral Suspension Dibutyl Sebacate Powdered Valerian Extract
Sodium Phenylbutyrate Oral Suspension Diethyl Sebacate Vitamin E Capsules
Sotalol Hydrochloride Oral Suspension Glyceryl Tristearate Vitamin E Preparation
Spironolactone and Hydrochlorothiazide Hypromellose meso-Zeaxanthin
Oral Suspension Isobutane meso-Zeaxanthin Preparation

December 2012 – Page 2

USPNF531W _ 2012-12