Pharmaceutical

Chinese Pharmacopoeia: Understanding 42 Guidelines [English Version Available]

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Chinese Pharmacopoeia is an official collection of drug standards, covering drug development, production, sale, utilization, supervision, and control in China. It is compiled by the Chinese Pharmacopoeia Commission. A new edition of Chinese Pharmacopoeia is regularly published every five years. The latest edition of Chinese Pharmacopoeia was released on July 2, 2020, and took effect on Dec. 30, 2020. It includes 5,911 monographs on 2,711 traditional Chinese medicines, 2,712 chemical drugs, 153 biologics, and 335 pharmaceutical excipients.

Contents of Chinese Pharmacopoeia 2020

Volume Content Number
Volume I Traditional Chinese medicine monographs 2,711
Volume II Chemical drug (including chemical APIs, also known as active pharmaceutical ingredients) monographs 2,712
Volume III Biologic product monographs 153
Volume IV General chapters General requirements for preparations 38
Testing methods and other requirements 281
Guidelines 42
Pharmaceutical excipients monographs 335
The Chinese Pharmacopoeia 2020 Edition also includes 361 general chapters, including 38 general requirements for preparations, 281 testing methods and other general chapters, and 42 guidelines.

42 Guidelines in Chinese Pharmacopoeia 2020

General Chapter No. Guideline
9001 Guidelines for the Stability Testing of Drug Substances and Preparations
9011 Guidelines for In Vivo Bioavailability and Bioequivalence Studies on Drug Preparations
9012 Guidelines for Validation of Quantitative Analytical Methods for Biological Samples
9013 Guidelines for Sustained, Controlled and Delayed Release Preparations
9014 Guidelines for Microparticle Preparations
9015 Guidelines for Studies and Quality Control of Drug Polymorphism
9099 Guidelines for Analytical Method Verification
9100 Guidelines for Analytical Method Transfer
9101 Guidelines for Analytical Method Validation
9102 Guidelines for the Analysis of Impurities in Drugs
9103 Guidelines for Hygroscopicity Trials for Pharmaceuticals
9104 Guideline for Near-infrared (NIR) Spectrophotometry
9105 Guidelines for Bioactive Assays of Traditional Chinese Medicines
9106 Guidelines for Pharmaceutical Evaluation Based on Microarrays
9107 Guidelines for DNA Barcoding for the Molecular Identification of Traditional Chinese Medicine Ingredients
9108 Technical Guidelines for DNA Sequencing
9109 Guidelines for the Establishment of Standard Nucleic Acid Sequences
9201 Guidelines for the Validation of Alternative Microbial Detection Methods for Pharmaceuticals
9202 Guidelines for Microbial Limit Tests for Non-sterile Products
9203 Guidelines for Quality Management of Microbiology Laboratory for Pharmaceutical Products
9204 Guidelines for Microbial Identification
9205 Guidelines for Microbiological Monitoring and Control of Clean Laboratories for Pharmaceutical Products
9206 Guidelines for Validation of Isolator Systems for Use and Application in Sterility Testing
9207 Guidelines for Biological Indicators for Sterilization
9208 Guidelines for Resistance Performance Tests for Biological Indicators
9251 Guidelines for the Application of Bacterial Endotoxin Tests
9301 Guidelines for the Application of Safety Tests for Injections
9302 Guidelines for Establishing Limits for Harmful Residues of Traditional Chinese Medicines
9303 Guidelines for Determination of Pigments
9304 Guidelines for Determination of Aluminium (Al), Chromium (Cr), Iron (Fe) and Barium (Ba) in Traditional Chinese Medicines
9305 Guidelines for Determination of Mycotoxins in Traditional Chinese Medicines
9306 Guidelines for Genotoxic Impurity Control
9401 Guidelines for Validation of Bioactivity/Potency Testing Methods for Biological Products
9402 Guidelines for Stability Testing of Biological Products
9501 Guidelines for Quality Control of Positron Emission Tomographic Radiopharmaceutical Preparations
9502 Guidelines for Quality Control of Technetium [99mTc] Radiopharmaceuticals
9601 Guidelines for Research and Evaluation on Functionality-related Characteristics of Pharmaceutical Excipients
9602 Guidelines for Pharmaceutical Excipients of Animal Origin
9603 Guidelines for Quality Control of Premixed and Co-processed Pharmaceutical Excipients
9621 Guidelines for General Requirements for Drug Packaging Materials and Containers
9622 Guidelines for Pharmaceutical Glass Materials and Containers
9901 National Guidelines for Preparation of Pharmaceutical Standard Substances
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