Modelo: BP/USP
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 |
Grupos de Producto : Ingrediente farmacéutico > Antivirus, Serie Anti-Fungals