|
Items |
Specification |
|
Appearance: |
White to yellowish,amorphous powder hygroscopic |
|
Identification
|
Test A (IR):
Test C (HPLC): |
Complies
Complies |
|
Solubility: |
Soluble in water, soluble in methanol, practically insoluble in methylene chloride. |
|
Specific rotation: |
+168 to +183 |
|
Heavy metals: |
Not more than 2ppm |
|
pH value: |
5.5-7.5 |
|
Sulfated ash: |
Not more than 0.2% |
|
Water: |
Not more than 4% |
|
Unknown single impurities: |
0.1% |
|
Related substance |
Impurity A
Impurity B
Impurity C
Impurity D
Impurity E
Impurity F
Impurity G
Impurity H |
Not more than 0.6%
Not more than 0.5%
Not more than 1.5%
Not more than 1.0%
Not more than 0.2%
Not more than 0.3%
Not more than 0.2%
Not more than 0.2% |
|
Total impurities: |
Not more than 3% |
|
Assay (on dry basis): |
Not less than 99% |
|
Absorbance: |
Not more than 0.15 at 125nm |
|
Particular size: |
100% pass 100 mesh sieve |
