CAS NO. :9007-28-7 | Pharmacopoeia standard :CP |
HS CODE :3001.9090.99 | File service :Chinese GMP/ DMF / EU-DMF |
Source:Porcinecartilagetissues such asthroatbone, nasal bone, trachea.
Characters:White oryellowish powder, saltish, odourless,hygroscopic.
Process:Chondroitin Sulfate (Injection)is extracted from healthyporcinecartilagetissues.
Test Items | CP | |
Characters | White or yellowish powder, saltish, odourless, hygroscopic | |
Identification | Produce cuprous oxide red precipitation: Conforms | |
Blue and purple spots: Conforms | ||
Sulfate: Conforms | ||
Tests | pH | 6.0~7.0(5%) |
Clarity and color | Clear(5%) | |
Nitrogen | 2.5%~3.5%(dry substance) | |
Chloride | ≤ 0.6% | |
Loss on drying | ≤ 10.0%(105℃, dry, 4h) | |
Absorbance | A260≤ 0.28;A280≤ 0.18 | |
Loss on drying | ≤ 20ppm | |
Molecular weight and distribution | MW: 35000~50000, Mw/Mn < 1.8 | |
Content | Hexosamine counted as glucosamine≥30.0%(dry substance) | |
Microbial Impurities | TAMC | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | |
E.coli | Conforms | |
Salmonella | Conforms |