Function: | Antithrombosis |
---|---|
Grade Standard: | Injectable Grade |
Type: | API |
State: | Powder |
Volatile: | Not Volatile |
Transport Package: | Aluminum Bottle |
Samples: |
---|
Suppliers with verified business licenses
Product Name | Enoxaparin sodium | Grade | Injectable | |
According to | EP 9.0 | |||
Items | Standards | Results | ||
Characters | A white or almost white powder | Almost white powder | ||
Solubility | Freely soluble in water | Complies | ||
Identification | Examine by nuclear magnetic resonance spectrometry | The spectrum obtained with the test solution is similar to specific low-molecular-mass heparin CRS. | Complies | |
1,6-anhydro derivatives | 15%-25% | 23.0% | ||
The ratio of anti-factor Xa activity to anti-factor II a activity | 3.3-5.3 | 4.8 | ||
Molecular distribution | `Mw:3800-5000 <2000:12.0%-20.0% 2000-8000:68.0%-82.0% |
4633 17.8% 70.1% |
||
Reaction of sodium | It gives reaction of sodium | Complies | ||
Appearance of solution | Clear and not more than intensity 6 | Complies | ||
PH | 6.2-7.7 | 6.9 | ||
Nitrogen | 1.5%-2.5%(Dry) | 2.0% | ||
Heavy metals | ≤30ppm | <30ppm | ||
Luminous absortion | 14.0-20.0 | 17.0 | ||
Benzyl alcohol | ≤0.1%(m/m) | 0.01% | ||
Sodium | 11.3%-13.5%(Dry) | 12.3% | ||
Residual solvent | Ethanol:≤5000ppm Methanol:≤3000ppm Dichloromethane:≤600ppm |
4000ppm 40ppm Not detectable |
||
Molar ratio of sulphate ions to carboxylate ions | ≥1.8 | 2.1 | ||
Loss on drying | ≤10.0% | 0.9% | ||
Bacterial endotoxin | ≤0.01 EU/A Xa IU | <0.01 EU/A Xa IU | ||
Microbiological examination | Total viable aerobic count:≤100cfu/g Fungi count:≤10cfu/g No pathogenic microorganisms(Escherichiacoil,Staphylococcus Aureus,Salmonella Species,Pseudomonas Aeruginosa,Bile-Tolerant Gram-Negative Bacteria) |
<10cfu/g <10cfu/g Not detectable |
||
Anti-factor II a activity | 20 IU/mg-35IU/mg(Dry) | 25IU/mg(wet 25 IU/mg) | ||
Anti-factor Xa activity | 90IU/mg-125IU/mg(Dry) | 119IU/mg(wet 118 IU/mg) |
Suppliers with verified business licenses