|
Items |
Specification |
Results |
|
Description |
Light orange to creamish white or off-white powder |
Off-white powder |
|
Solubility |
Soluble in acetic acid; sparingly soluble in chloroform; practically insoluble in water. |
Meet the requirements |
Identification |
A:Comparison:Oxcarbazepine CRS. |
Sample spectrum is similar to that of reference standard. |
|
B:The retention time of the major peak in the sample solution corresponds to that chromatogram of the standard solution , as obtained in the Assay. |
The retention time of the major peak in the sample solution corresponds to that ofchromatogram of thestandard solution , as obtained in the Assay. |
|
Residue on ignition |
0.1 % |
0.04% |
|
Water determination |
0.5 % |
0.05% |
Related substances |
Carbamazepine ≤0.5 % |
0.00% |
|
Oxcarbazepine related compound E ≤0.05% |
Not detected |
|
Methoxycarbamazepine≤0.05% |
0.01% |
|
Carbamazepine related compound B ≤0.05% |
Not detected |
|
Methoxydibenzazepine≤0.05% |
Not detected |
|
Any individual unspecified impurity≤0.05% |
0.04% |
|
Total impurities≤1.0% |
0.05% |
Residual Solvents |
Methanol≤3000ppm |
90ppm |
|
Methylene chloride≤600ppm |
86ppm |
|
Assay |
98.0~ 102.0 % |
99.7% |
|
Particle Size |
90%≤20μm |
conform |
