China Consults on 11 Packaging Material Standards in Pharmacopoeia
Jul. 15th, 2022
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| 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
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