Analytical Items |
Specifications |
Analytical Results |
Conclusion |
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 |
Pass |
Identification |
Positive reaction |
Conform to the requirement |
Pass |
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 |
Pass |
Acidity(pH) |
3.5 to 5.5 |
5.4 |
Pass |
Specific Optical Rotation |
+107° to +121° |
+120° |
Pass |
Methanol |
1.0% Not more than 1.0 percent |
Confbnn to the requirement |
Pass |
Composition |
Cl 25.0 to 50.0 percent |
25.5% |
Pass |
Cla 10.0 to 35.0 percent |
29.1% |
Pass |
C2a+C2 25.0 to 55.0 percent |
45.4% |
Pass |
Water |
Not more than 15.0 percent |
9.9% |
Pass |
Sulfated Ash |
Not more than 1.0 percent |
0.3% |
Pass |
Sulfate |
32.0% to 35.0% percent |
32.5% |
Pass |
Bacterial endotoxins |
Not more than 1.67 lU/mg |
Not more than 1.67 lU/mg |
Pass |
Assay |
Not less tlian 590 lU/mg (Anhydrous substance) |
646 lU/mg |
Pass |
Hydrous substance |
582 lU/mg |
|
Conclusion:Complies With The Standard of The British Pharmacopoeia 2002/European Pharmacopoeia 4.0. |