List of USP General Chapters for Pharmaceutical Industry

USP General Chapter

As per USP, the general chapter provide guidelines on activities related to the tests and procedures in the monographs.

General chapters may contain description of tests and procedures, general information on the interpretation of compendial requirements, or general guidance on official substances or official products.


USP general chapters numbered <1 to 999> discuss on General tests and Assays,  numbered above <1,000 to 1999> discuss on general information, and the numbered <2000 to 2999> discuss on dietary supplements.

List of USP General Chapter

In this article, we are mentioning a list of USP general chapter which are important for pharmaceutical industry professional.

〈1〉 Injections and Implanted Drug Products (Parenterals) - Product Quality Tests

〈2〉 Oral Drug Products - Product Quality Tests

〈3〉 Topical and Transdermal Drug Products - Product Quality Tests

〈4〉 Mucosal Drug Products—Product Quality Tests

〈5〉 Inhalation and Nasal Drug Products General Information and Product Quality Tests

〈7〉 Labeling

〈51〉 Antimicrobial Effectiveness Testing

〈85〉 Bacterial Endotoxins Test

〈601〉 Inhalation and Nasal Drug Products - Aerosols, Sprays, and Powders - Performance Quality Tests

〈607〉 Pharmaceutical Foams - Product Quality Tests

〈616〉 Bulk Density and Tapped Density of Powders

〈643〉 Total Organic Carbon

〈645〉 Water Conductivity

〈659〉 Packaging and Storage Requirements

〈660〉 Containers – Glass

〈661〉 Plastic Packaging Systems and Their Materials of Construction

〈698〉 Deliverable Volume

〈701〉 Disintegration

〈705〉 Quality Attributes of Tablets Labeled as Having A Functional Score

〈711〉 Dissolution

〈731〉 Loss On Drying

〈755〉 Minimum Fill

〈771〉 Ophthalmic Products - Quality Tests

〈785〉 Osmolality and Osmolarity

〈786〉 Particle Size Distribution Estimation by Analytical Sieving

〈788〉 Particulate Matter in Injections

〈791〉 pH

〈795〉 Pharmaceutical Compounding - Nonsterile Preparations

〈797〉 Pharmaceutical Compounding - Sterile Preparations

〈800〉 Hazardous Drugs – Handling in Healthcare Settings

〈852〉 Atomic Absorption Spectroscopy

〈857〉 Ultraviolet-Visible Spectroscopy

〈905〉 Uniformity of Dosage Units

〈921〉 Water Determination

〈1001〉 In Vitro Release Test Methods for Parenteral Drug Preparations

〈1010〉 Analytical Data - Interpretation and Treatment

〈1033〉 Biological Assay Validation

〈1059〉 Excipient Performance

〈1078〉 Good Manufacturing Practices for Bulk Pharmaceutical Excipients

〈1079〉 Good Storage and Distribution Practices for Drug Products

〈1083〉 Supplier Qualification

〈1086〉 Impurities in Drug Substances and Drug Products

〈1088〉 In Vitro and In Vivo Evaluation of Dosage Forms

〈1091〉 Labeling of Inactive Ingredients

〈1092〉 Dissolution Procedure: Development and Validation

〈1094〉 Capsules - Dissolution Testing and Related Quality Attributes

〈1095〉 Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units

〈1097〉 Bulk Powder Sampling Procedures

〈1117〉 Microbiological Best Laboratory Practices

〈1151〉 Pharmaceutical Dosage Forms

〈1174〉 Powder Flow

〈1210〉 Statistical Tools for Procedure Validation

〈1216〉 Tablet Friability

〈1217〉 Tablet Breaking Force

〈1220〉 Analytical Procedure Life Cycle

〈1231〉 Water for Pharmaceutical Purposes

〈1236〉 Solubility Measurements

〈1467〉 Residual Solvents - Verification of Compendial Procedures and Validation of Alternative Procedures

〈1469〉 Nitrosamine Impurities

〈1604〉 Data Interpretation of Aerodynamic Particle Size Distribution Measurements for Orally Inhaled Products

〈1665〉 Characterization of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products

〈1705〉 Quality Attributes of Tablets Labeled as Having a Functional Score

〈1711〉 Oral Solid Dosage Forms - Dissolution Testing

〈1724〉 Semisolid Drug Products - Performance Tests

〈1790〉 Visual Inspection of Injections

〈1852〉 Atomic Absorption Spectroscopy - Theory and Practice

〈1857〉 Ultraviolet-Visible Spectroscopy - Theory and Practice

〈2021〉 Microbial Enumeration Tests—Nutritional and Dietary Supplements

〈2022〉 Microbiological Procedures for Absence of Specified Microorganisms—Nutritional and Dietary Supplements

〈2040〉 Disintegration and Dissolution of Dietary Supplements

〈2091〉 Weight Variation of Dietary Supplements

〈2232〉 Elemental Contaminants in Dietary Supplements

〈2800〉 Multi-Ingredient Dietary Supplement Products - Development of Quality Tests

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