| Remark : The Above material complies as per the EP Specification |
 |
|
ITRACONAZOLE |
|
Product : Itraconazole - EP |
| TEST |
SPECIFICATION |
RESULT |
| DESCRIPTION | A WHITE OR ALMOST WHITE POWDER | A WHITE POWDER |
| IDENTIFICATION BY IR | IR SPECTRUM | COMPLIES |
| MELTING RANGE | 166-170 degree C | 168-170 degree C |
| LOSS ON DRYING | MAXIMUM 0.5 % | 0.35 % |
| SULPHATED ASH | MAXIMUM 1.0 % | COMPLIES |
| OPTICAL RATATION | -0.10 TO 0.10 | COMPLIES |
| RELATION SUBSTANCE (BY HPLC) | TO COMPLY AS PER EP | COMPLIES |
| ASSAY (CHEMICAL) | NLT 98.5% NMT 101.5 % | 99.65% |
| Remark : The Above material complies as per the EP Specification |
|