ITEM | STANDARD | RESULTS |
Appearance | White to off-white powder | White powder |
Identification | IR/ HPLC | Complies |
Residue On Ignition | NMT 0.2% | 0.05% |
Heavy Metals | NMT 20ppm | LESS THAN 10ppm |
Loss On Drying | NMT 0.5% | 0.32% |
Related Substances (By HPLC) Single Impurity Total Impurity |
NMT 0.5% NMT 1.0% |
0.06% 0.2% |
Assay (By HPLC) | 98.0-102.0% | 99.8% |