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Clotrimazole, sold under the brand name Canesten among others, is an antifungal medication. It is used to treat vaginal yeast infections, oral thrush, diaper rash, pityriasis versicolor, and types of ringworm including athlete's foot and jock itch. It can be taken by mouth or applied as a cream to the skin or in the vagina.
Specification:
|
Items |
Specifications |
Results |
|
|
Clotrimazole |
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 |
||
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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 |
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Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
