S.No |
Test |
Specification |
1. |
Description |
Light yellow to yellowish colour crystalline powder. |
2. |
Solubility |
Freely Soluble in methanol, methylene dichloride, acetone, sparingly soluble in water |
3. |
Melting point range |
Between 90°C and 96°C |
4. |
Identification |
|
by IR |
The sample and standard IR spectra are concordant. |
5. |
Moisture content |
Not more than 0.5%. |
6. |
Loss on drying |
Not more than 1.0%. |
7. |
Related impurities by HPLC |
|
a. Individual impurity |
Not more than 0.5%. |
b. total impurities |
Not more than 1.0%. |
8. |
Purity by HPLC |
Not less than 99% |