S.No |
Test |
Specification |
1 |
Description |
A white to off-white colour crystalline powder |
2 |
Solubility |
Soluble in Methanol, Ethyl acetate. Slightly soluble Methylene dichloride. Insoluble in Water |
3 |
Identification by IR |
IR chromatograph of sample should be similar to In-house standard |
4 |
Melting range |
118°C – 122ºC |
5 |
Loss on drying |
Not more than 1.0% |
6 |
Sulphated ash |
Not more than 0.2% |
7 |
Related Impurities by HPLC |
|
|
a. Individual impurity |
Not more than 0.5% |
|
b. Total impurity |
Not more than 1.0% |
8 |
Purity by HPLC |
Not less than 99.0% |