API TESTING SPECIFICATION

Name: Carbamazepine BP

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

Code: HCMZ

CAS: 298-46-4

Storage: In an airtight container.

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

M.F.: C15 H12 N2 O

M.W.: 236.3g/mole

 

Test

 

Specification

Characters

:

White or almost white crystalline powder. It should show polymorphism; the acceptable crystalline form should correspond to Carbamazepine CRS.

Solubility

:

Very slightly soluble in water, freely soluble in methylene chloride, sparingly soluble in acetone and in alcohol.

Identification A (Melting point)        

:

189.00C to 193.00C

Identification B       

:

The Infra-red absorption spectrum should be concordant with the reference spectrum of Carbamazepine CRS.

Acidity or alkalinity

:

Colour should be red after addition of 0.05 ml of phenolphthalein solution and 0.01 M of 0.5 ml sodium hydroxide solution respectively. Then after addition of 1 ml of  0.01 M hydrochloric acid solution should be colourless , which should be red after addition of 0.15 ml of methyl red solution

Related substance  (By HPLC )

:

Impurity A (10, 11- dihydrocarbamazepine): NMT 0.10%.
Impurity E (Iminodibenzyl): NMT 0.10%.
Ant other impurity: NMT 0.10%.

Total Impurities: NMT 0.50%.

Chlorides

:

NMT 140 ppm

Heavy metals

:

NMT 20 ppm

Loss on drying

:

NMT 0.50%w/w

Sulphated ash

:

NMT 0.100%w/w

Assay

:

98.00 to 102.00% w.r.t dried substance.

End of specification