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Enoxaparin sodium: GMP, COA, DMF available

Enoxaparin sodium: GMP, COA, DMF available
Product Detailed
Related Categories:Pharmaceutical
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



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