API TESTING SPECIFICATION

Name: Carbamazepine USP

T.S.No.: SPEC/API/HCMZ-021/D/01
Issue Date: 01/03/2006

Code: HCMZ

CAS: 298-46-4

Storage: Preserve in tight containers.

Supersede: SPEC/API/HCMZ-021/D
Date: 01/04/2002

M.F.:  C15 H12 N2 O

M.W.: 236.27g/mole

 


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