Sr No. |
Parameter |
Specification |
1 |
Description |
Off white to dark brown color powder |
2 |
Identification By HPLC |
The retention time of the major peak in the chromatogram of sample solution corresponds to that in the chromatogram of standard solution as obtained in Chromatographic purity by HPLC. |
3 |
Water Content by KF(w/w) |
Not more than 2.0% |
4 |
Chromatographic Purity by HPLC ( % area) |
Not less than 96.0 |
5 |
Single Maximum Impurity by HPLC |
Not more than 2.0 |
6 |
Total impurities by HPLC |
Not more than 4.0 |