[Introduction] The notice shows that the general principles of physical and chemical analysis in the four parts of the 2020 edition of the "Chinese Pharmacopoeia" have added and revised 11 items of physical and chemical analysis contents.

On August 23, the State Pharmacopoeia Commission announced the additions and revisions to the four general chapters of the 2020 edition of the "Chinese Pharmacopoeia" and formed the (first batch) draft for soliciting opinions, with a public display period of three months.

The notice shows that the four general principles of physical and chemical analysis of the 2020 edition of the "Chinese Pharmacopoeia" have added and revised 11 physical and chemical analysis contents, including Raman spectroscopy, X-ray diffraction, melting point determination, freezing point determination, pH determination, thermal analysis, moisture determination, residual solvent determination, methanol content test, disintegration time test, and crystallinity test.

The 2020 edition of the General Principles of Biological Testing in Part IV of the "Chinese Pharmacopoeia" added and revised the bacterial endotoxin test method and the protamine sulfate titer determination method.

The four general microbiological chapters of the 2020 edition of the "Chinese Pharmacopoeia" added and revised the sterility inspection method, guidelines for microbial identification, guidelines for microbial monitoring and control in pharmaceutical clean laboratories, guidelines for validation and application of isolation systems for sterility inspection, guidelines for biological indicators for sterilization, guidelines for biological indicator tolerance test methods, and bacterial DNA characteristic sequence identification methods.

The new and revised contents of the general preparations section of the four parts of the 2020 edition of the "Chinese Pharmacopoeia" are the guiding principles for sustained-release, controlled-release and delayed-release preparations.

Announcement on the additions and revisions to the four general chapters of the 2020 edition of the Chinese Pharmacopoeia

All relevant units:

In accordance with the relevant requirements of the compilation outline of the 2020 edition of the Chinese Pharmacopoeia, our commission organized and carried out the addition and revision of the four general rules of the 2020 edition of the Chinese Pharmacopoeia. Based on extensive solicitation of opinions and the results of relevant scientific research projects organized by our commission, the drafting of the four relevant general rules was completed, and after review by the relevant professional committees of the 11th Pharmacopoeia Commission, a draft for comments (first batch) was formed (see Appendix 1 for details). In order to further improve the content of the general rules of the pharmacopoeia, our commission’s website is now open for public comments, and the public notice period is three months.

Please carefully review and provide relevant opinions, modification suggestions and specific explanations to our Commission (see Attachment 2). The letter should indicate the recipient unit "China Pharmacopoeia Commission", affix the official seal of the unit, and indicate the contact person and telephone number; at the same time, send the word version of the letter to the contact email address, and please indicate "General Feedback + Unit" in the email title.

Mailing address: Office of the Chinese Pharmacopoeia Committee, Building 11, Fahua South Lane, Dongcheng District, Beijing (receive) Postal code: 100061

Fax: 010-67152769

E-mail: ywzhc@chp.org.cn

Contact person and contact information

Physics and Chemistry: Xu Xinyi (Tel: 010-67079522)

Preparation: Shangyue (Tel: 010-67079578)

Microbiology and biological testing: Xu Huayu (Tel: 010-67079521)

Appendix 1: Draft for comments on the four general rules of the 2020 edition of the Chinese Pharmacopoeia (first batch)

　1. Additions and revisions to the four general principles of physical and chemical analysis in the 2020 edition of the Chinese Pharmacopoeia

0421 Raman spectroscopy.pdf

0451 X-ray diffraction method.pdf

0612 Melting point determination.pdf

0613 Condensation point determination method.pdf

0631 pH value determination method.pdf

0661 Thermal Analysis.pdf

0832 Moisture Determination Method.pdf

0861 Residual Solvent Determination Method.pdf

　0871 Methanol quantity inspection method.pdf

　0921 Disintegration time test method.pdf

0981 Crystallinity Test Method.pdf

2. Additions and revisions to the four general rules for biological testing in the 2020 edition of the Chinese Pharmacopoeia

1143 Bacterial Endotoxin Test.pdf

1213 Protamine sulfate titer determination method.pdf

3. Additions and revisions to the four general chapters on microorganisms in the 2020 edition of the Chinese Pharmacopoeia

1101 Sterility Test Method.pdf

　9204 Guidelines for Microbiological Identification.pdf

9205 Guidelines for Microbiological Monitoring and Control in Pharmaceutical Clean Laboratories.pdf

9206 Guidance for validation and application of isolation systems for sterility testing.pdf

Guidelines for biological indicators for sterilization.pdf

Guidelines for Biological Indicator Tolerance Test.pdf

Bacterial DNA characteristic sequence identification method.pdf

4. Additions and revisions to the general preparations section of the four parts of the 2020 edition of the Chinese Pharmacopoeia

9013 Guidelines for sustained-release, controlled-release and delayed-release preparations.pdf

Attachment 2:

Feedback form.doc

National Pharmacopoeia Committee

August 23, 2018