Items:

Requirements             

Results

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 to 5.5

5.1

Specific optical rotation :

+107°to +121°

+116°

Methanol :

Not more than 1.0 percent

Complies

Composition:

C1            25.0 to 50.0  per cent

27.4  %

C1a      10.0 to 35.0  per cent

25.6  %           

C2a + C2  25.0 to 55.0  per cent

47.0  %            

Water:

Not more than 15.0 per cent

8.5  %             

Sulphated ash :

Not more than 1.0  per cent

0.5   %             

Sulphate:

32.0 to 35.0 per cent

33.7 %         

Sterility:

Complies with the test for sterility

Complies

Bacterial endotoxin:

Not more than 1.67 IU/mg

< 0.71  IU/mg       

Assay:

Not less than 590 IU/ mg ((anhydrous substance))

656  IU/mg

(hydrous substance)

600  IU/mg