Product Name : CARBAMAZEPINE
Molecular Formula : C15H12N2O
Molecular Weight : 236.27
Synonyms : 5H-Dibenz[b,f]azepine, 5-carboxamide & 5H- Dibenz[b,f]azepine-5-carboxamide
CAS No : 298-46-4
| Sr. No. | Test | Specifications |
|---|---|---|
| 1 | Description | White to off-white powder. |
| 2 | Solubility | Soluble in alcohol and in acetone, practically insoluble in water. |
| 3 | Identification – By IR By HPLC |
The IR absorption spectrum of the test preparation
should exhibits maxima at the same wavelength as that
of a similar preparation of Carbamazepine working
standard. Retention time of main peak in test preparation to be concordant in the assay. |
| 4 | Chlorides and Sulphates (%w/w) | Meet the requirement |
| 5 | Residue on ignition (%w/w) | Not more than 0.1 |
| 6 | Organic Impurities (By HPLC) Carbamazepine related compound A Carbamazepine related compound B Any individual impurity Total impurities (By TLC, % w/w) |
Not more than 0.2 Not more than 0.2 Not more than 0.2 Not more than 0.5 |
| 7 | Acidity | Not more than 1ml of 0.01N sodium hydroxide solution is required for each 1.0 gm of carbamazepine. |
| 8 | Alkalinity | Not more than 1ml of 0.01N hydrochloric acid solution is required for each 1.0 gm of carbamazepine. |
| 9 | Loss on Drying (% w/w) | Not more than 0.5 |
| 10 | Heavy Metal | Not more that 10ppm |
| 11 | X-Ray Diffraction | The X -ray diffraction pattern should conform to that of USP Carbamazepine. |
| 12 | Assay (By HPLC, % w/w, ODB). |
between 98 and 102. |