On July 11, the Chinese Pharmacopoeia (ChP) Commission announced that it would conduct systemic researches on the standards of colorants as pharmaceutical excipients, as an effort to improve drug safety and quality controllability.
The ChP Commission is currently asking for public advice on colorant standards. The target colorants include but are not limited to
Colorants used in pediatric drugs;
Colorants widely used in pharmaceuticals;
Colorants whose current quality control standards are incomplete, especially for operation;
Colorants whose current standards cannot meet the need for medical use.
Colorants 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 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.
Related Database
Get Access to Chinese Pharmacopoeia Standards of APIs and Excipients
Related Webinar
ChemLinked BaiPharm Webinar: Understanding Chinese Pharmacopoeia (ChP) 2020
