ITEM

SPECIFICATIONS

RESULTS

Characters

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

A white powder ,freely soluble in water ,practically insoluble in alcohol and in ether

Identification

Positive Reaction

Conform to the requirement

Appearance of solution

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

Conform to the requirement

Acidity (pH)

3.5 ~5.5

5.3

Specific Optical Rotation

+107°to +121°

+115°

Methanol

Not more than 1.0% percent

Conform to the requirement

Composition

C₁  25.0% to 50.0%

25.8%

C_1a  10.0% ~35.0%

26.1%

C_2a+C₂   25.0% ~55.0%

48.1%

Water

Not more than 15.0%

8.4%

Sulfated ash

Not more than 1.0%

0.7%

Sulfate

32.0% ~35.0%

33.9%

Bacterial endotoxins

Not more than 1.67 IU/mg

Not more than 1.67 IU/mg

Assay

Not less than 590 IU/mg (Anhydrous substance)

594 IU/mg

Hydrous substance

544 IU/mg

Conclusion: It conforms to the requirements of BP2002/EP4.0