Item

Specifications

Results

Characters

White or almost white powder,freely soluble in water,practically insoluble in alcohol and in ether

Complies

Identification

Tests according to monograph

Complies

Appearance of solution

Clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color

Complies

PH

3.5 to 5.5

4.4

Specific optical rotation

+107°to +121°

+117°

Methanol

Not more than 1.0 percent

Complies

Composition

C1:25.0 to 55.0 percent

27.5%

C1a:10.0 to 35.0 percent

30.1%

C2a +C2:25.0 to 55.0 percent

42.4%

Water

Not more than 15.0 percent

8.6%

Sulphated ash

Not more than 1.0 percent

0.4%

Sulphate

32.0 to 35.0 percent

33.4%

Sterility

Complies with the test for sterility

Complies

Bacterial endotoxins

Less than 1.67 IU/mg

<0.71 IU/mg

Assay

Not less than 590 IU/mg(anhydrous substance)

670 IU/mg

(hydrous substance)

612 IU/mg

Conclusion

The results conforms with BP2002/EP4 standards.