|
ITEM |
STANDARD |
RESULTS |
|
Appearance |
White or almost white crystalline powder |
White crystalline powder |
|
Dissolution |
Easily solubale in water, solubale in 95% alcohol |
Complies |
|
Indentification |
(1) Should be positive respond
(2) IR graphs should be conforms to the reference standard
|
Complies |
|
Clarity |
should be not more than 1# working standard solution |
Complies |
|
Color |
Should be lighter than the standard solution |
Complies |
|
Optical transmission |
Not less than 95% |
99.2% |
|
Water |
19.0~21.0% |
19.66% |
|
Chlorides |
Not more than 0.01% |
Complies |
|
Sulfates |
Not more than 0.05% |
Complies |
|
Residual organic solvents |
Not more than 0.3% of methanol
Not more than 0.5% of ethanol
|
Not detected
0.35%
|
|
Sulfated ash |
Not more than 0.1% |
Complies |
|
Relative substance |
Total impurity not more than 0.5% |
0.055% |
|
Heavy Metal |
Not more than10ppm |
Complies |
|
Microbiological quality |
Should meet the requirements |
Complies |
|
Bacterial endotoxins |
Not more than 0.35 IU/mg |
Complies |
|
Assay |
99.0%~ 101.0% |
99.89% |
|
Conclusion |
The product complies to Enterprise standard |
|