List USP General Chapters untuk Industri Farmasi

General Chapter
Sesuai USP, bab umum memberikan pedoman kegiatan yang berkaitan dengan pengujian dan prosedur dalam monografi.

USP general chapter

Bab umum dapat berisi uraian pengujian dan prosedur, informasi umum tentang penafsiran persyaratan ringkasan, atau pedoman umum mengenai bahan resmi atau produk resmi.

Bab umum USP bernomor <1 hingga 999> membahas tentang Tes Umum dan Tes, bernomor di atas <1.000 hingga 1999> membahas tentang informasi umum, dan bernomor <2000 hingga 2999> membahas tentang suplemen makanan.

Berikut daftar General chapter
Pada artikel ini, kami menyebutkan daftar bab umum USP yang penting bagi profesional industri farmasi.


〈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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