China Seeks Public Advice on Colorant Standards of Drug Excipients [English Form Available]
On July 11, the Chinese Pharmacopoeia (ChP) Commission announced that it would conduct systemic research on the standards of colourants as pharmaceutical excipients, in an effort to improve drug safety and quality controllability.
The ChP Commission is currently asking for public advice on colourant standards. The target colourants include but are not limited to
- Colourants used in pediatric drugs;
- Colourants widely used in pharmaceuticals;
- Colourants whose current quality control standards are incomplete, especially for operation;
- Colourants whose current standards cannot meet the need for medical use.
Colourants not included in the Chinese Pharmacopoeia are also open for public comments.
If you have any relevant advice and comments, please fill in the following table and send it as an Excel file to sunjian_0000@163.com before August 20, 2022.
| Advice on the Pharmaceutical Excipient Standards of Colorants | ||||
| Name of the Pharmaceutical Excipient | The Currently Effective Standard | Problems with the Currently Effective Standard | Whether Samples Can Be Provided | Workplace, Name, and Contact Information |
| (Please fill in ChP Standard, National Standard, Registration Standard, or Company\’s Internal Standard.
Please include the non-ChP standards in an attachment.) |
(Please describe the problems in detail.) | (Please fill in \”yes\” or \”no\”.) | ||
You\’re also welcomed to contact BaiPharm for translating the Chinese Pharmacopoeia 2020 Edition\’s standards covering
- active pharmaceutical ingredients, excipients, and packaging materials;
- finished dosage forms of chemical drugs and biological products;
- testing methods;
- guidelines, etc.
Reprinted from: ChemLinked
Reference Links
Webinar: Understanding Chinese Pharmacopoeia (ChP) 2020
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