Characters

A 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

3.5-5.5

4.7

Specific optical rotation

+107° to +121°

+117°

Methanol

Not more than 1.0%

Complies

Composition

C1 25.0 to 50.0%

C1a 10.0 to 35.0%

C2a+C2 25.0 to 55.0%

25.3%

27.8%

46.9%

Water

Not more than 15%

9.6%

Sulphated ash

Not more than 1.0%

0.2%

Sulphate

32.0 to 35.0%

34.3%

Sterility

Complies with the test for sterility

Complies

Bacterial endotoxin

Not more than 0.71 IU/mg

Complies

Assay

Not less than 590 IU/mg

(anhydrous substance)

(hydrous substance)

666 IU/mg

602 IU/