Chinese Pharmacopoeia: Understanding 42 Guidelines [English Version Available]

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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