Chondroitin Sulfate
【Approval No.】 GUOYAOZHUNZI H51023843
CAS NO. : 9082-07-09 | Pharmacopoeia standard :CP |
HS CODE : 3001.9090.99 | File service :Chinese GMP / DMF / EU-DMF |
Source:Porcine cartilage tissues such as throat bone, nasal bone, trachea.
Characters:White or yellowish powder, saltish, odourless, hygroscopic.
Process:Chondroitin Sulfate (Injection) is extracted from healthy porcine cartilage tissues.
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 |
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