Item |
Specification |
Results |
Appearance |
Pale yellow to off-white powder |
Conforms |
Identification |
a) IR:IR chromatograph Conforms to the characteristic peak of R.S. |
Conforms |
b) HPLC :The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R.S. |
Conforms |
|
Residue on ignition |
≤ 0.1% |
0.07% |
Loss on drying |
≤1.0% |
0.35% |
Heavy Metals |
≤20 ppm |
Conforms |
Related substance |
|
|
Single impurity |
≤0.50% |
0.22% |
Total impurities |
≤1.0% |
0.61% |
Assay[HPLC] |
≥99.0% |
99.51% |
Conclusion |
The results comply with standards of enterprise. |
Produktgruppe : Pharmazeutische Serie