Chinese Pharmacopoeia 2020 by four General Revision 11 physical and chemical analysis content

[REVIEW] notice shows that "Chinese Pharmacopoeia" 2020 edition four physical and chemical analysis by General Revision 11 physical and chemical analysis content.

August 23, the State Pharmacopoeia Commission published the 2020 edition of "Chinese Pharmacopoeia" by four General revisions, and the formation of (the first) draft, public notice period of three months.

Notification display, "Chinese Pharmacopoeia" 2020, four chemical analysis General by Amendment 11 chemical analysis content, including Raman spectroscopy, X-ray diffraction, melting point determination method, freezing point assay, pH value measuring method, thermal analysis, water assay, assay of residual solvents, the amount of methanol inspection method, disintegration Test method, crystallinity inspection method.

"Chinese Pharmacopoeia" in 2020 by four bioassays General Revision of bacterial endotoxin test, protamine sulfate potency assay.

"Chinese Pharmacopoeia" 2020 General upgrading four microbial sterility test, microbiological monitoring and control guidelines for microbial identification guidelines, pharmaceutical laboratory clean, sterile isolation system check verification and application guidelines for use, sterilization biological indicators guidelines, biological indicator test for tolerance guidelines, characterized in bacterial DNA sequence identification method.

"Chinese Pharmacopoeia" in 2020 by four General part of preparations for the amendments slow and controlled release guidelines and delayed release formulations.

Publicity about the "Chinese Pharmacopoeia" in 2020 by four General of amendments

The relevant units:

According to "Chinese Pharmacopoeia" 2020 edition compiled outline the requirements, our commission organized by the revision of 2020 edition of "Chinese Pharmacopoeia" of four General. On the basis of the results of research projects related to solicit opinions on the organization and our commission to complete the drafting of the relevant general rule of four, and by the eleventh Pharmacopoeia Commission to consider the relevant professional committees, formed a draft (the first) ( see Annex 1), in order to further improve the content Pharmacopoeia General, now I appointed website for public comment, public notice period of three months.

Please carefully study the relevant units of nuclear, relevant comments and proposed changes specify the feedback I appointed (see Annex 2). Letter must indicate receipt by unit "State Pharmacopoeia Commission", stamped with the official seal of the unit, and indicate contact person and telephone; at the same time send a letter word version to the contact email, please indicate the message header "General feedback + units."

Address: Dongcheng District, Beijing law office in South China Building 11, National Pharmacopoeia Commission (Received) Zip Code: 100061

Fax: 010-67152769


Contact Details

Physical and chemical: Xu Xin Yi (Tel: 010-67079522)

Formulation: Shangyue (Tel: 010-67079578)

Microbes and bioassay: Xu Huayu (Tel: 010-67079521)

Annex 1: "Chinese Pharmacopoeia" 2020 edition four General draft (the first)

  1. "Chinese Pharmacopoeia" 2020 General physical and chemical analysis by four amendments

0421 Raman spectroscopy .pdf

0451 X-ray diffraction method .pdf

0612 .pdf assay m.p.

0613 Determination of solidification point .pdf

0631 pH value assays .pdf

0661 Thermal Analysis .pdf

0832 Determination of water .pdf

0861 Determination of residual solvent .pdf

  0871 test for the amount of methanol .pdf

  Disintegration Test Method 0921 .pdf

0981 test for crystalline .pdf

2. "Chinese Pharmacopoeia" 2020 version of the four amendments by bioassay General

1143 within the bacterial endotoxin test .pdf

1213 fish protamine sulfate titer assay .pdf

3. "Chinese Pharmacopoeia" in 2020 by four General microorganisms amendments

1101 sterility test .pdf

  9204 Microbial Identification Guidelines .pdf

9205 Drug clean laboratory microbiological monitoring and control guidelines .pdf

9206 sterility test verification isolation system and application guidelines .pdf

Biological indicators for sterilization guidelines .pdf

Guidelines tolerance test for biological indicators .pdf

Bacterial DNA sequence identification method wherein .pdf

4. "Chinese Pharmacopoeia" 2020 edition four General preparation part by amendments

9013 slow and controlled release, and delayed release formulations guidelines .pdf

Annex 2:

Feedback single .doc

State Pharmacopoeia Commission

August 23, 2018

source:Jinan Shing Electronic Technology Co., Ltd.

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