-
Introduction
-
Specification
-
-
Low molecular weight heparin calcium (
LMWH-Ca
) is a new kind of antithrombotic drug. It is obtained by depolymerization of heparin. The average molecular weight of LMWH-Ca is about 4500 Da. LMWH-Ca has obvious anti-factor Xa activity and affects the clotting time to a less degree than heparin.
The LMWH-Ca injection is mainly indicated for deep vein thrombosis and pulmonary embolism, hemodialysis, and unstable coronary artery disease
(unstable angina and Non-Q-Wave myocardial infarction) and so on.
|
Test |
Acceptance criteria |
|
Origin |
Porcine intestinal mucosa |
| White or almost white powder, hygroscopic. Freely soluble in water |
|
|
Identification
|
A：13C-NMR B：Anti-factor Ⅹ a / Anti-factor Ⅱa is not less than 1.5 C：the mass-average relative molecular mass is not greater than 8000 . ＜8000: not less than 60.0% D：complies with the test for calcium |
|
Anti-factor Ⅹa activity |
Not less than 70 IU/mg |
| The ratio of Anti-factor Ⅹa / Anti-factorⅡa |
Not less than 1.5 |
|
pH |
5.5~8.0 |
|
Nitroge |
1.5%~2.5% |
|
Calcium |
9.5%~11.5% |
|
Nucleotide and protein impurities of the source material |
260nm: not greater than 0.20 280nm: not greater than 0.15 |
|
Molar ratio of sulfate ions to carboxylate ions |
Not less than 1.8 |
|
Heavy metals |
Not more than 30 ppm |
|
Nitrite |
Complie |
|
Loss on drying |
Not more than 10.0% |
|
Bacterial endotoxins |
Less than 0.01 IU/AⅩaIU |