On July 13, the Chinese Pharmacopoeia (ChP) Commission released the drafts of 3 general chapters and 8 determination methods of rubber closures as pharmaceutical packaging materials.
The drafts are currently under consultation until August 13. Before that, comments on the general chapters can be sent to xujun@shpmcc.com and opinions on the testing methods can be sent to jiangyan@scsyjs.org.
General Chapters |
5200 Rubber Closures for Pharmaceutical Packaging |
5201 Rubber Closures for Packaging Injections |
5202 Rubber Closures for Packaging Oral Dosage Forms |
Determination Methods |
4204 Determination of Extractables and Leachables of Pharmaceutical Packaging Materials |
4206 Determination of Insoluble Particles in Pharmaceutical Packaging Materials |
4214 Determination of Metal Elements and Ions in Pharmaceutical Packaging Materials |
4219 Determination of Volatile Sulfide in Rubber Closures |
4220 Determination of Ash Content in Rubber Closures |
4221 Determination of Water Content in Rubber Closures |
4222 Determination of Silicone Oil on the Surface of Rubber Closures |
4223 Determination of Special Residues of Silicone Rubber Closures |
If you need English versions of the drafts, please contact BaiPharm for translation service. BaiPharm can also provide the translation of the Chinese Pharmacopoeia 2020 Edition's Standards covering
active pharmaceutical ingredients, excipients, 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
