clotrimazole crystalline

ITEMS

SPECIFICATIONS

RESULTS

CHARACTIMAZOLE

A WHITE OR CRYSTALLINE WHITE POWDER.

COMPLIES

iDENTIFICATION

IR SPECTRUM

SIMILAR to the USP CLOTRIMAZOLE RS

COMPLIES

TLC TEST

PRINCIPAL SPOT IS SIMILAR TO THE 

REFERENCE SOLUTION

COMPLIES

SOLUBILITY

PRACTICALLY INSOLUBLE IN WATER,SOLUBLE

 IN ALCOHOL AND IN METHYLENE CHLORIDE 

SLIGHT SOLUBLE IN ETHER

COMPLIES

RELATED COMPOUND A

(O-CHOROPHENYL)-

DIPHENYLMETHANOL≤0.2%

COMPLIES

EACH KNOWN IMPURITY≤0.2%

COMPLIES

EACH UNKNOWN IMPURITY≤0.2%

COMPLIES

SUM OF ALL IMPURITIES≤0.5%

COMPLIES

IMIDAZOLE

NOT MORE THAN 0.2%

<0.2%

LOSS ON DRYING

NOT MORE THAN 0.5%

0.1%

RESIDUE ON IGNITION

NOT MORE THAN 0.1%

0.01%

HEAVY METALS

NOT MORE THAN 0.001%

<0.001%

ASSAY

98.5-100.5% (C22H17CLN2)

99.8%

RESIDUAL SOLVENT

BENZENE≤2PPM

TOLUENE≤890PPM

COMPLIES

COMPLIES

CONCLUSION:UP TO THE USP32/BP2009