China Consults on 11 Packaging Material Standards in Pharmacopoeia
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 draft is 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.
Reprinted from: ChemLinked
Reference Links
- ChP Commission Consults on 3 General Chapters of Rubber Seals as Pharmaceutical Packaging Materials
- ChP Commission Consults on 8 Testing Methods of Rubber Seals as Pharmaceutical Packaging Materials
- Webinar: Understanding Chinese Pharmacopoeia (ChP) 2020
- More news on pharmaceutical regulations
Contact Us
BaiPharm, a subsidiary of REACH24H Consulting Group, is specialized in pharmaceutical industry consultancy services. With our experts across China, Japan, South Korea, the United States, and Europe, BaiPharm is fully qualified to engage in complex market entry projects of finished drugs, APIs, excipients, and packaging materials for most key markets.
If you have any questions about pharmaceutical regulatory compliance in China, please feel free to contact us.
Tel: +86 (0)571-87007555
Email: customer@reach24h.com
