TESTS | SPECIFICATIONS |
Description | A White or almost white , crystalline powder |
Solubility | Practically insoluble in water ,Springly soluble in methanol and slightly in ethanol(96%)and in methylene chloride |
Identification | |
A)By IR | A)IR spectrum of test preparation should be concordant with that standard |
B)Melting Point | B)Between 182°C to 192°C |
Apperance of Solution | The solution is clear and not more intensely colored than reference solution BY6 |
Specific Optical Rotation(On dried Basis) | Between -60° to -70° |
Heavy Metals | Max 10ppm |
Chlorides | Not more than 100ppm |
Sulphated Ash | Not more than 0.1 % |
Loss on Drying | Not more than 0.5 % |
Related substance | |
A)By TLC | Impurity A:Not more than 0.1 % |
B)By HPLC | Single Impurity:Not more than 0.5 % |
| Total Impurities:Not more than 1.0 % |
Assay (On Dried Basis) | Between 98.5 to 101.0 % |
| |
PACKING: | 25Kg Fiber Drum/HDPE Drum with double inner polythene bag |