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CAS NO. :9082-07-9 | Pharmacopoeia standard ：CP / EP / USP |
HS CODE :3001.9090.99 | File service：Chinese GMP / DMF |
Source：Porcinecartilagetissues such asthroatbone, nasal bone, trachea.
Characters：White oralmostwhitepowder,hygroscopic.
Process：ChondroitinSulfate Sodiumisextracted from healthyporcinecartilagetissues.
Test Items | CompanySpecification | |||
CP | EP | USP | ||
Characters | White or almost white powder, hygroscopic | White or almost white powder, hygroscopic | ||
Identification | IR graph:Conforms | IR graph:Conforms | IR graph:Conforms | |
Sodium:Conforms | Sodium:Conforms | Sodium:Conforms | ||
———— | Electrophoresis: Conforms | Disaccharide composition: Conforms | ||
Tests | Clarity | ———— | ———— | Clear: A420≤ 0.35 (5%) |
Specific Rotation | -25°~ -32° | -20。～ -30。（5%） | -20。～ -30。（30mg/ml） | |
Intrinsic viscosity | ———— | 0.01～0.15m3/kg | ———— | |
Related substances | ———— | Conforms | Conforms | |
pH | 6.0～7.0 | 5.5～7.5（5%） | 5.5～7.5（1%） | |
Loss on drying | ≤ 10.0%（105℃ 4h） | ≤ 12.0%（105℃ 4h） | ≤ 12.0%（105℃ 4h） | |
Residue on ignition | 20.0%～30.0%（dry substance） | ———— | 20.0%～30.0%（dry substance） | |
Chloride | ≤ 0.5% | ≤ 0.5% | ≤ 0.5% | |
Sulfate | ≤ 0.24% | ———— | ≤ 0.24% | |
Heavy metal | ≤ 20ppm | ≤ 20ppm | ≤ 20ppm | |
ElectrophoreicPurity | ———— | Conforms | ||
Protein | ———— | ≤ 3.0%（dry substance） | ≤ 6.0%（dry substance） | |
Residual solvent | Conforms | Conforms | Conforms | |
Nonspecific disaccharides | ———— | ≤ 10.0% | ||
Content | 90.0～105.0%（dry substance） | 95.0～105.0% (dry substance) | 90.0～105.0%（dry substance） | |
Microbial Impurities | TAMC | ≤ 1000cfu/g | ≤ 1000cfu/g | ≤ 1000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Conforms | Conforms | Conforms | |
Salmonella | Conforms | Conforms | Conforms | |
Staphylococcus aureus | ———— | Conforms | ———— | |
Pseudomonas aeruginosa | ———— | Conforms | ———— | |
Bile-Tolerant Gram-Negative Bacteria | ———— | ≤ 100cfu/g | ———— | |
CRO
