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. Note—In 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
Biological Tests and Assays

81 Antibiotics—Microbial 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 Protein—Biological Adequacy Test (deleted)
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
Reagents, Indicators, and Solutions
Chromatographic Columns
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)