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Carbamazepine

Carbamazepine

 



5H-Dibenz(b,f)azepine-5-carboxamide BP/USP/EP 

C15H12N2O
Mol. Wt.: 236.3
CAS 298-46-4
 
Description
White to off-white crystalline powder.
 
Solubility
Almost insoluble in water; soluble in 10 parts of chloroform; sparingly soluble in alcohol (96%) and in acetone.
 
Identification
The infra-red absorption spectrum is concordant with the spectra of Carbamazepine EPCRS and USP, RS.
 
X-ray Diffraction
Pattern conforms to that of USP Carbamazepine Reference Standard.
 
Loss on Drying
Not more than 0.1%.
 
Clarity and Colour of Solution
A 10% solution in chloroform is clear, and almost colourless.
 
Acidity/Alkalinity
Complies BP/USP/EP
 
Heavy Metals
Less than 20ppm.
 
Chromatographic Purity
USP - total impurities:NMT 0.5%.
 
Related Substances
BP/EP - passes test.
 
Other Tests
Complies BP/USP/EP requirement.
 
Assay
Not less than 98% and not more than 102% of  C15H12N2O calculated on the dried substance.
 
Medical Use
Antiepileptic, analgesic in trigeminal neuralgia.


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