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Product Name: Miconazole Nitrate
Expiry Date: 3 YEARS Specification: USP42 Particle size: 100% less than 200μm |
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Test item |
Specification |
Results |
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Appearance |
White or almost white powder |
Complies |
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Identification |
IR |
Similar to standard |
Complies |
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The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay |
Complies |
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Appearance of solution |
The solution is clear and not more intensely cloured than reference solutions Y7 |
Complies |
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Solubility |
Insoluble in ether, very slightly soluble in water and in isopropyl alcohol, slightly soluble in alcohol, in chloroform and in propylene glycol, sparingly soluble in methanol, soluble in dimethyl formamide, freely soluble in dimethyl sulfoxide |
Complies |
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Optical rotation |
-0.1°- + 0.1° |
0° |
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Related substance |
Deschlorobenzyl econazole |
≤0.25% |
Complies |
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Miconazole quarternary salt |
≤0.25% |
Complies |
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Miconazole benzyl analog |
≤0.25% |
Complies |
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Miconazole related compound C |
≤0.25% |
Complies |
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Miconazole related compound I |
≤0.25% |
Complies |
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Econazole nitrate |
≤0.25% |
Complies |
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Miconazole 2,6-isomer |
≤0.25% |
Complies |
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Miconazole 2,5-isomer |
≤0.25% |
Complies |
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Miconazole related compound F |
≤0.25% |
Complies |
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anyIndividual unspecified impurity |
≤0.10% |
Complies |
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Total impurity |
≤0.5% |
0.31% |
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Melting point |
178-184℃ |
181.0-182.0℃ |
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Loss on drying |
≤0.5% |
0.15% |
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Residue on ignition |
≤0.2% |
0.04% |
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Residue solvents |
Toluene |
≤890ppm |
120ppm |
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Ethanol |
≤5000ppm |
110ppm |
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Benzyl chloride |
≤1000ppm |
100ppm |
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2,4-Dichlorobenzyl chloride |
≤1000ppm |
N/A |
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Assay (on dry basis) |
98.0-102.0% |
99.5% |
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Conclusion |
Complies with the requirement of USP42 |
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