It is a white to white crystalline powder and belongs to the antifungal drug.
CAS No. :
22832-87-7EINECS :
245-256-6Package :
25kg/drumBrand :
TOPINCHEM®Origin :
CHINAFormula :
C18H14Cl4N2O.HNO3Minimum Order :
25KGItem :
Miconazole NitrateDescription
Miconazole nitrate is an antifungal drug, the same one commonly used to treat ringworm.
Specification
|
TEST ITEM |
ACCEPTANCE CRITERIA | RESULTS |
| Appearance | White or almost white powder. | White powder |
| Solubility | Very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol(96%) | Complies |
| Identification |
A. Melting point :178-184 ℃ B. Infrared adsorption spectropotometry C. Thin-layer chromatography D. The reaction of nitrates |
A. 182-183 ℃ B. Complies C. Complies D. Complies |
| Appearance of solution | Solution S is clear and not more intensely coloured than reference solution Y7 | Complies |
| Opticalrotation | -0.10°~+0.10° | 0 ° |
| Related substances |
Impurity A:≤0.25% Impurity B:≤0.25% Impurity C:≤0.25% Impurity D:≤0.25% Impurity E:≤0.25% Impurity F:≤0.25% Impurity G:≤0.25% Unspecified impurities:≤0.10% Total impurities≤0.5% |
Not detected Not detected Not detected Not detected Not detected Not detected 0.13% 0.06% 0.19% |
| Loss on drying | ≤0.5% | 0.18% |
| Sulfated ash | ≤0.1% | 0.05% |
| Assay | 99.0%-101.0%(dried substance) | 99.75% |
| Residual Solvents |
Benzene:≤2ppm Methylbenzene≤890ppm |
No detected 25ppm |
| Microorganism |
Total aerobic bacteria:≤1000 cfu/g Total yeasts and molds:≤100 cfu/g E. coli,S. aureus, P. aeruginosa& C. albicans: absent per g. |
<10cfu/g <10cfu/g Absent |
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