Test |
|
Specification |
Description |
: |
White to off-white powder. |
Solubility |
: |
Practically insoluble in water, soluble in ethanol, and in acetone. |
Identification (By IR) |
: |
The Infrared absorption spectrum is concordant with the spectrum obtained from Carbamazepine standard or reference IR spectrum graph. |
X ray diffraction |
: |
The X ray diffraction pattern confirms to that of RS/WS determined similarly. |
Acidity |
: |
Not more than 1 ml of 0.01 N sodium hydroxide should be require for each gm of Carbamazepine. |
Alkalinity |
: |
Not more than 1 ml of 0.01 N Hydrochloric acids should be require for each gm of Carbamazepine. |
Loss on drying |
: |
Not more than 0.50%w/w |
Residue on ignition |
: |
Not more than 0.100%w/w |
Chloride |
: |
Not more than 0.014% |
Heavy metals |
: |
Not more than 0.001%. |
Chromatographic Purity |
: |
Any individual impurity: Not more than 0.2%.
Total impurities: Not more than 0.5% (Including 10, 11-dihydrocarbamazepine and Iminostilbene) |
Residual solvents |
: |
Acetone not more than 5000.00 ppm.
Methanol not more than 3000.00 ppm. |
Assay |
: |
98.00 to 102.00% w.r.t dried substance. |
End of specification |