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 |