Items tested

Specifications

Characters   (01/2008:1097)

A white or almost white powder.  Hydroscopic.
Freely soluble in water

Identification

A: 13C NMR Spectrum  (2.2.33)

B: Anti-FXa/Anti-FIIa 3.3 to 5.3  (01/2008:0828)

C: The weight-average molecular weight is 4500Da, the range being between 3800 and 5000Da
The percent has a molecular weight of less than 2000Da, the range being between 12.0% and 20.0%
The percent has molecular weight of between 2000 and 8000Da, the range being between 68.0% and 82.0%  (2.2.30)

D: it gives reaction of sodium (2.3.1)

1H-NMR Spectrum  (2.2.33)

The sample should be free from OSCS

Appearance of solution
(2.2.1 &2.2.2 method II)

Dissolve 1.0g in 10ml of water R, the solution is clear and not more intensely colored than intensity 6 of the range of reference solutions of the most appropriate color

Specific absorbance  (2.2.25)

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

Bacterial endotoxins (2.6.14)

<0.01IU/Anti-FXa IU activity

pH at a concentration  of 10%
(2.3.3)

6.2 to7.7

Loss on drying  (2.3.2)

≤10.0%

Nitrogen  (2.5.9)

1.5% to 2.5%

Heavy metals  (2.4.8)

≤30ppm

Sodium content
(2.3.23 method I)

11.3% to 13.5%

SO42-/COO-   (01/2008:0828)

≥1.8

Benzyl alcohol
(01/2008:1097 & 2.2.29)

≤0.1%(m/m)

Limit of residual solvents CH2Cl2  (2.3.28)

≤600ppm

Methanol  (2.3.28)

≤3000ppm

Anti-FXa (01/2008:0828)

90 IU to 125 IU/mg

Anti-FIIa (01/2008:0828)

20 IU to 35 IU/mg

1,6-anhydro derivative
USP/NF Supplement <207>

15.0~25.0%

Conclusion

Complies with the requirements of EP7.0