- Contact Person : Mr. Shen Jinhang
- Company Name : Changzhou Taikang Pharmaceutical Co., Ltd.
- Tel : 86-519-81667066
- Fax : 86-519-86567888
- Address : Jiangsu,Changzhou,Guoxiang Road 18, Wujing Economic Zone, Changzhou, Jiangsu
- Country/Region : China
- Zip : 213149
Low molecular weight heparin sodium
Definition
Low molecular weight heparin sodium, sodium salt of sulfated glucosaminoglycans having an average molecular weight less than 8000 and for which at least 60 per cent of the total molecular weight has a relative molecular weight less than 8000. The potency is not less than 70 IU of anti-factor Xa activity per milligram, calculated with reference to the dried substance. The ratio of anti-factor Xa activity to anti-factor IIa activity, determined as described under Assay, is not less than 1.5.
Specification
TEST | Acceptance criteria | |
Characters | White or almost white powder, hygroscopic | |
Solubility | Freely soluble in water | |
Identification | A. Anti-Xa/ Anti-IIa | NLT 1.5 |
B. Sodium | Complies | |
Appearance of solution | Complies | |
pH | 5.5-8.0 | |
Absorbance | OD260nm: NMT 0.20 OD280nm: NMT 0.15 | |
Nitrite | Complies | |
Nitrogen | 1.5%-2.5% (dried substance) | |
Sodium | 9.5%-12.5% (dried substance) | |
[-OSO3-]/[-COO-] | NLT 1.8 | |
Average molecular weight and molecular weight distribution | Mw: Less than 8000 <8000: NLT 60% | |
Heavy metals | NMT 30ppm | |
Loss on drying | NMT 10.0% | |
Residual Solvents | NMT 0.5% | |
Bacterial endotoxins | NMT 0.01EU/IU | |
Ethanol | NMT 0.5% | |
Potency( Anti-factor Xa) | NLT 70 IU/mg (dried substance) | |
Low molecular weight heparin sodium