Chinese Pharmacopoeia Commission Seeks Public Advice on Colorant Standards

by Grace Wang Jul 18, 2022


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 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.pngChemLinked BaiPharm Webinar: Understanding Chinese Pharmacopoeia (ChP) 2020

Grace Wang
ChemLinked Regulatory Analyst / Editor
Copyright: unless otherwise stated all contents of this website are ©2023 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact