Listing ID #7166625
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SR.NO |
TEST |
SPECIFICATION |
RESULT |
1. |
Description |
Off white to yellow brown or dark brown crystals or powder |
Yellowish brown powder |
2. |
Identification by HPLC |
The retention time of the principal peak from the test sample chromatogram should correspond to that of standard |
Complies |
3. |
Loss on drying (% w/w) |
Not more than 1.0% |
0.09% |
4. |
Related substances by HPLC (%) A)   1,2-Difluoro – 4 nitro benzene B)    Z1-1 (4-(2-fluoro -4-nitrophenyl) morpholine C)    Maximum single unknown impurity D)   Total impurity |
 Not more than 0.2%  Not more than 0.3%   Not more than 0.5%  Not more than 1.0% |
 ND  ND   0.07%  0.08% |
5. |
Assay by HPLC |
Not less than 98.0% and not more than 102.0% |
99.8% |