Enoxaparin Sodium complies with 1. Speicfication: EP 7.0, USP34 2. Injectable Grade
Definition
Enoxaparin sodium is the sodium salt of low molecular weight heparin obtained by alkaline depolymerization of the benzyl ester derivative of heparin from pork intestinal mucosa.
Usage
Enoxaparin sodium is indicated for prophylaxis of deep vein thrombosis (DVT), treatment of acute DVT with or without plumonary embolism, prohpylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infactions (MI) and so on.
Specification
Test | Acceptance criteria |
Origin | Porcine intestinal mucosa |
Characters | White or almost white, hygroscopic powder |
Identification | A:13C-NMR B:the mass-average relative molecular mass ranges between 3800 and 5000, with a characteristic value of about 4500. <2000: 12.0%~20.0% 2000~8000: 68.0%~82.0% |
Anti-factor Xa activity | 90 IU/mg~125 IU/mg |
Anti-factor IIa activity | 20.0 IU/mg~35.0 IU/mg |
The ratio of Anti-factor Xa / Anti-factor IIa | 3.3~5.3 |
Appearance of solution | Clear and not more intensely colored than intensity 6 of reference solution |
pH | 6.2~7.7 |
Specific absorbance | 231nm: 14.0~20.0 |
Benzyl alcohol | Not more than 0.1%(m/m) |
Sodium | 11.3%~13.5% |
Nitrogen | 1.5%~2.5% |
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 20 ppm |
Loss on drying | Not more than 10.0% |
Bacterial endotoxins | Less than 0.01 IU/AXaIU |
Enoxaparin sodium: GMP, COA, DMF available
