Enoxaparin Sodium 679809-58-6

Product Information

COA

ANALYSIS

SPECIFICATION

RESULTS

Appearance

White or almost white powder,

White powder

Solubility

Hygroscopic.

Solubility: Freely soluble in water

Complies

Identification

A: 13C-NMR: the spectrum should be similar with that of standard. Ethanol peak may exist at 18.7ppm±0.5ppm, benzaledyde peak may exist at 131.6ppm±0.5ppm and130.9ppm±0.5ppm in spectrum obtained from test sample.

The spectrum of test solution is similar to that of enoxaparin sodium RS, Ethanol peak exist at 18.7ppm±0.5ppm. No benzaldehyde peak exist at 131.6ppm±0.5ppm and 130.9ppm±0.5ppm.

B: 1,6 anhydro derivative: 15% to 25%

20.3%

C: The mass-average relative molecular mass ranges between 3800 and 5000 Da.

The mass percentage of chains lower than 2000 Da. ranges bwtween 12.0% and 20%

The mass percentage of chains between 2000 and 8000 ranges between 68.0% and 82.0%

The mass-average relative molecular mass : 4384

The mass percentage of chains lower than 2000 Da.: 18.9%

The mass percentage of chains between 2000 and 8000 Da.: 70.7%

D: Anti-factor Xa/Anti-factor IIa: 3.5 to 5.3

3.4

E: Sodium: It complies with the test of sodium

Complies

Appearance of solution

The solution is clear and not more intensely colored than reference solution

Complies

Specific absorbance

The specific absorbance determined at 231 nm ranges between 14.0 and 20.0(dried substance)

17.3

Bacterial endotoxins

< 0.01 IU/Anti-FXa U activity

< 0.01 IU/Anti-FXa U activity

pH

6.2 to 7.7

7.1

Loss on drying

≤10.0%

1.4%

Nitrogen

1.5% to 2.5% (on dried substance)

2.0%

Sodium content

11.3%-13.5%(on dried substance)

12.4%

SO₄^2-/COO^-

≥1.8

2.4

Benzyl alcohol

≤0.1%(m/m)

0.02%

Residual solvents

DMF ≤880ppm

Below detection limit

Ethanol≤5000ppm

891ppm

Anti-factor Xa activity

90IU to 125 IU/mg(on dried substance)

981 IU/mg

Anti-factor IIa activity

20.0IU to 35.0IU(on dried substance)

28.8IU/mg

Micro organisms

A:

TAMC: ≤ 100CFU/g

TYMC: ≤ 10CFU/g

< 10CFU/g

<10CFU/g

B:

Specified micro organisms

Escherichia coli

Salmonella

Negative

Negative

Negative

Free sulfate content

≤0.50%

0.11%

Conclusion

The sample complies with the requirements of EP10.5.

Usage