Understanding 42 Guidelines in the Chinese Pharmacopoeia

by Grace Wang Aug 30, 2022

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.

The 42 guidelines are listed as follows. 

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

 Contact BaiPharm If you need English translations of the guidelines or any other standards of APIs, excipients, and finished drug products in the Chinese Pharmacopoeia.get-access-to-english-translation-of-chinese-pharmacopoeia-standards.pngGet Access to English Translation of Chinese Pharmacopoeia Standards

chemlinked-baipharm-webinar-understanding-chinese-pharmacopoeia-chp-2020.pngChemLinked BaiPharm Webinar: Understanding Chinese Pharmacopoeia (ChP) 2020

 

Grace Wang
ChemLinked Regulatory Analyst
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