ANNOTATED LIST
General Notices, Monographs, General Chapters, Reagents, and Tables Affected by Changes Appearing in USP 35
Page citations refer to the pages of USP 35. NoteIn the table below, if a section is new or if a subsection is added to or deleted from an existing section, it is labeled as such in parentheses after the section or subsection name. Items on this list that appear without the designation new, added, or deleted are items in which changes have been made to existing official text.
General Chapters
General Tests and Assays
General Requirements for Tests and Assays
1 Injections Nomenclature and Definitions 3 Topical and Transdermal Drug ProductsProduct Quality Tests (new)
Biological Tests and Assays
81 AntibioticsMicrobial Assays 85 Bacterial Endotoxins Test Determination of Maximum Valid Dilution (MVD) Gel-Clot Technique 88 Biological Reactivity Tests, In Vivo Classification of Plastics Implantatation Test 141 ProteinBiological Adequacy Test (deleted)
Limit Tests
Other Tests and Assays
401 Fats and Fixed Oils Ester Value Fatty Acid Composition Trace Metals Sterol Composition 467 Residual Solvents Limits of Residual Solvents
Physical Tests and Determinations
General Information
1113 Microbial Characterization, Identification, and Strain Typing (new) 1116 Microbiological Control and Monitoring of Aseptic Processing Environments 1128 Nucleic Acid-Based TechniquesMicroarray (new) 1151 Pharmaceutical Dosage Forms 1224 Transfer of Analytical Procedures (new) 1226 Verification of Compendial Procedures Verification Process Verification Requirements
Dietary Supplements
Reagents, Indicators, and Solutions
Reagent Specifications
Volumetric Solutions
Reference Tables
Container Specifications for Capsules and Tablets
Alprazolam Tablets, Orally Disintegrating Fish Oil Containing Omega-3 Acids Capsules, Delayed-Release Loratadine Tablets, Orally Disintegrating Orlistat Capsules Risperidone Tablets, Orally Disintegrating Tramadolol Hydrochloride Tablets, Extended-Release
Description and Relative Solubility of USP and NF Articles
Candesartan Cilexetil Ethylcellulose Dispersion Type B Polyglyceryl Dioleate Hydrogenated Starch Hydrolysate Temozolomide Valganciclovir Hydrochloride
Monographs (Dietary Supplements)
Chamomile ADDITIONAL REQUIREMENTS Labeling Cranberry Liquid Preparation ADDITIONAL REQUIREMENTS Labeling Eleuthero DEFINITION IDENTIFICATION Test A Test B (added) COMPOSITION Content of Eleutherosides B and E (subsections Standard solution A, Standard solution B, Standard solution C, Sample solution, System suitability, and Analysis) CONTAMINANTS Microbial Enumeration Tests Absence of Specified Microorganisms (added) ADDITIONAL REQUIREMENTS USP Reference Standards Powdered Eleuthero IDENTIFICATION Test A Test B (added) COMPOSITION Content of Eleutherosides B and E (subsections Standard solution A, Standard solution B, Standard solution C, Sample solution, System suitability, and Analysis) CONTAMINANTS Microbial Enumeration Tests Absence of Specified Microorganisms (added) ADDITIONAL REQUIREMENTS USP Reference Standards Powdered Eleuthero Extract DEFINITION IDENTIFICATION Test A Test B (added) COMPOSITION Content of Eleutherosides B and E (subsections Standard solution A, Standard solution B, Standard solution C, Sample solution, System suitability, and Analysis) CONTAMINANTS Microbial Enumeration Tests (added) Absence of Specified Microorganisms (added) ADDITIONAL REQUIREMENTS USP Reference Standards Fish Oil Containing Omega-3 Acids Delayed-Release Capsules (new) Ginger ADDITIONAL REQUIREMENTS Labeling Powdered Ginger IDENTIFICATION Test A (added) Test B (added) Test C (added) SPECIFIC TESTS Other Requirements (deleted) ADDITIONAL REQUIREMENTS Labeling Ginger Capsules ADDITIONAL REQUIREMENTS Labeling Ginger Tincture ADDITIONAL REQUIREMENTS Labeling Ginkgo IDENTIFICATION COMPOSITION Content of Flavonol Glycosides CONTAMINANTS Heavy Metals (added) Microbial Enumeration Tests Absence of Specified Microorganisms (added) SPECIFIC TESTS Loss on Drying ADDITIONAL REQUIREMENTS USP Reference Standards Powdered Ginkgo Extract IDENTIFICATION Test A Test B COMPOSITION Content of Flavonol Glycosides CONTAMINANTS Heavy Metals (added) Microbial Enumeration Tests Absence of Specified Microorganisms (added) SPECIFIC TESTS Other Requirements ADDITIONAL REQUIREMENTS USP Reference Standards Ginkgo Capsules IDENTIFICATION Test A STRENGTH Content of Flavonol Glycosides CONTAMINANTS Microbial Enumeration Tests (added) Absence of Specified Microorganisms (added) ADDITIONAL REQUIREMENTS USP Reference Standards Ginkgo Tablets IDENTIFICATION Test A STRENGTH Content of Flavonol Glycosides CONTAMINANTS Microbial Enumeration Tests (added) Absence of Specified Microorganisms (added) ADDITIONAL REQUIREMENTS USP Reference Standards Alpha Lipoic Acid IDENTIFICATION Test A Test B (added) ASSAY Procedure (subsections Buffer solution, Mobile phase, Standard solution, Sample solution, and System suitability) IMPURITIES Chromatographic Purity, Procedure 1 (subsections Buffer solution, Mobile phase, Standard solution, Diluted standard solution, and System suitability) Malabar-Nut-Tree, Leaf (new) Powdered Malabar-Nut-Tree, Leaf (new) Powdered Malabar-Nut-Tree, Leaf Extract (new) Phyllanthus Amarus (new) Powdered Phyllanthus Amarus (new)
Monographs (USP 35)
Alprazolam Orally Disintegrating Tablets (new) Aztreonam ASSAY Procedure (subsection Chromatographic system) Bisoprolol Fumarate Tablets PERFORMANCE TESTS Dissolution (subsection Test 1) Red Blood Cells (delete) Platelets (delete) Budesonide DEFINITION ASSAY Procedure (subsection Acceptance criteria) Candesartan Cilexetil (new) Carmustine for Injection ASSAY Procedure (subsection Chromatographic system) Cefdinir IMPURITIES Organic Impurities (subsections System suitability solution 3, System suitability, Analysis, and Acceptance criteria) Cefdinir Capsules IMPURITIES Organic Impurities (subsection Acceptance criteria) Cefdinir for Oral Suspension IDENTIFICATION Test A (deleted) Test B IMPURITIES Organic Impurities (subsection Acceptance criteria) SPECIFIC TESTS Loss on Drying (deleted) Clindamycin Hydrochloride IDENTIFICATION Test A Test B (added) ASSAY Procedure (subsections Mobile phase and System suitability) Clonidine Transdermal System PERFORMANCE TESTS Drug Release (subsection Test 3) Deferoxamine Mesylate DEFINITION ASSAY Procedure (subsection Acceptance criteria) IMPURITIES Organic Impurities (subsection Acceptance criteria) Docetaxel Injection (new) Donepezil Hydrochloride IDENTIFICATION Test A IMPURITIES Organic Impurities, Procedure 1 Organic Impurities, Procedure 2 (added) SPECIFIC TESTS Water Determination ADDITIONAL REQUIREMENTS Labeling (added) USP Reference Standards Drospirenone ASSAY Procedure (subsections Solution A, Solution B, Mobile phase, Diluent, System suitability solution, Standard solution, Sample solution, Chromatographic system, System suitability, and Analysis) Estradiol Transdermal System DEFINITION ASSAY Procedure (subsection Acceptance criteria) Estrone Injection (delete) Fluconazole Injection ASSAY Procedure (subsection Buffer) IMPURITIES Organic Impurities (Note and subsections Procedure 2, Procedure 3, and Procedure 4) Glycopyrrolate CHEMICAL INFORMATION DEFINITION IDENTIFICATION Test B ASSAY IMPURITIES Ordinary Impurities (deleted) Organic Impurities (added) Limit of Erythro Isomer (added) SPECIFIC TESTS Melting Range or Temperature (deleted) ADDITIONAL REQUIREMENTS Packaging and Storage USP Reference Standards Glycopyrrolate Tablets IDENTIFICATION ASSAY PERFORMANCE TESTS Dissolution (subsections Buffer, Mobile phase, Standard stock solution, Standard solution, Sample solution, Chromatographic system, and System suitability) IMPURITIES Organic Impurities (added) ADDITIONAL REQUIREMENTS Packaging and Storage USP Reference Standards Hydrocortisone Acetate CHEMICAL INFORMATION SPECIFIC TESTS Optical Rotation Hydromorphone Hydrochloride IMPURITIES Organic Impurities (subsections Procedure 1 and Procedure 2) ADDITIONAL REQUIREMENTS USP Reference Standards Hydromorphone Hydrochloride Oral Solution IDENTIFICATION Test A (deleted) Test B Ivermectin Paste DEFINITION ASSAY Procedure (subsection Acceptance criteria) IMPURITIES Organic Impurities (subsections Analysis and Acceptance criteria) Lamotrigine Tablets ASSAY Procedure (subsection Sample solution) PERFORMANCE TESTS Dissolution (subsection Test 1 and Test 3) IMPURITIES Organic Impurities (subsection Sample solution) Lansoprazole ASSAY Procedure (subsections Diluent, Standard solution, Sample solution, and Analysis) IMPURITIES Organic Impurities ADDITIONAL REQUIREMENTS USP Reference Standards Levetiracetam Tablets PERFORMANCE TESTS Dissolution (subsections Test 1 and Test 2) ADDITIONAL REQUIREMENTS Labeling (added) Levofloxacin Oral Solution (new) Loratadine Oral Solution SPECIFIC TESTS pH Loratadine Orally Disintegrating Tablets (new) Losartan Potassium Tablets PERFORMANCE TESTS Dissolution (subsections Test 1 and Test 2) ADDITIONAL REQUIREMENTS Labeling (added) Mercaptopurine IDENTIFICATION Test A Test B ASSAY Procedure (subsections Solution A, Mobile phase, Standard stock solution, Standard solution, Sample stock solution, Sample solution, Chromatographic system, System suitability, and Analysis) IMPURITIES Inorganic Impurities (added) Organic Impurities (added) ADDITIONAL REQUIREMENTS Packaging and Storage USP Reference Standards Mercaptopurine Tablets IDENTIFICATION Test A Test B ASSAY Procedure (subsections Solution A, Solution B, Solution C, Mobile phase, Diluent, Standard solution, Sample stock solution, Sample solution, Chromatographic system, System suitability, and Analysis) PERFORMANCE TESTS Dissolution (subsection Tolerances) IMPURITIES Organic Impurities (added) Methyldopa IDENTIFICATION Test A Morphine Sulfate Extended-Release Capsules PERFORMANCE TESTS Dissolution (subsection Mobile phase) Mycophenolate Mofetil Capsules IMPURITIES Limit of Degradation Products (subsection Acceptance criteria) Ondansetron Tablets PERFORMANCE TESTS Dissolution (subsections Test 1, Test 3, and Test 6) Orlistat (new) Orlistat Capsules (new) Oxybutynin Chloride Extended-Release Tablets PERFORMANCE TESTS Dissolution (subsection Test 2) Phenoxybenzamine Hydrochloride Capsules IDENTIFICATION Test A Primaquine Phosphate ASSAY Procedure IMPURITIES Organic Impurities (added) ADDITIONAL REQUIREMENTS USP Reference Standards Primaquine Phosphate Tablets IDENTIFICATION Test B ASSAY Procedure PERFORMANCE TESTS Uniformity of Dosage Units (subsection Procedure for content uniformity) IMPURITIES Organic Impurities (added) ADDITIONAL REQUIREMENTS USP Reference Standards Protein Hydrolysate Injection (delete) Risperidone Orally Disintegrating Tablets (new) Rosiglitazone Maleate (new) Sertraline Tablets PERFORMANCE TESTS Dissolution ADDITIONAL REQUIREMENTS Labeling (added) Spironolactone IDENTIFICATION Test A SPECIFIC TESTS Optical Rotation Talc ADDITIONAL REQUIREMENTS Labeling Tazobactam CHEMICAL INFORMATION SPECIFIC TESTS Water Determination ADDITIONAL REQUIREMENTS Labeling (added) Telmisartan IMPURITIES Heavy Metals Telmisartan Tablets PERFORMANCE TESTS Dissolution (subsection Sample solution) Temazepam ASSAY Temozolomide (new) Tramadol Hydrochloride Tablets PERFORMANCE TESTS Dissolution (subsection Sample solution) Tramadol Hydrochloride Extended-Release Tablets (new) Trandolapril DEFINITION ASSAY Vasopressin DEFINITION ASSAY Procedure (subsections Analysis and Acceptance criteria) Vinblastine Sulfate ASSAY Procedure (subsection System suitability solution) ADDITIONAL REQUIREMENTS USP Reference Standards Vinblastine Sulfate for Injection ASSAY Procedure (subsection System suitability solution) ADDITIONAL REQUIREMENTS USP Reference Standards Vincristine Sulfate CHEMICAL INFORMATION IDENTIFICATION Test A ASSAY Procedure (subsections Standard solution, System suitability solution, and Sample solution) ADDITIONAL REQUIREMENTS USP Reference Standards Vincristine Sulfate Injection IDENTIFICATION Test A ASSAY Procedure (subsections Standard solution, System suitability solution, and Sample solution) IMPURITIES Organic Impurities ADDITIONAL REQUIREMENTS USP Reference Standards Vincristine Sulfate for Injection IDENTIFICATION Test A ASSAY Procedure (subsections Standard solution, System suitability solution, and Sample solution) PERFORMANCE TESTS Uniformity of Dosage Units (subsection Standard solution) ADDITIONAL REQUIREMENTS USP Reference Standards Vinorelbine Tartrate CHEMICAL INFORMATION IDENTIFICATION Test B ASSAY Procedure (subsections System suitability solution and System suitability) IMPURITIES Organic Impurities (subsection Acceptance criteria) Zolpidem Tartrate Extended-Release Tablets PERFORMANCE TESTS Dissolution (subsections Test 1, Test 2, and Test 3) IMPURITIES Organic Impurities (subsection Acceptance criteria) ADDITIONAL REQUIREMENTS Labeling (added) |