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Test |
Limits |
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Description
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A white to creamy white crystalline powder
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Solubility
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Soluble in methanol and chloroform, sparingly soluble in acetone and insoluble in water.
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Identification
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A. Infrared spectrophotometry as same as Fluconazol CRS.
A. UV spectrum is as same as Fluconazol CRS.
B. TLC RF value of test and Fluconazol CRS are the same.
C. RT main peak in sample solution is the same as in STD solution
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Melting range
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136°C - 140°C.
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Clarity and color of solution
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0.2% solution in water is clear and colorless.
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Related substances HPLC
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The area of any peak apart from the principle peak is not grater than 0.5%, the sum of such
area not grater than 1.0%.
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Heavy metals
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Not more than 20 ppm.
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Loss on drying
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Not more than 1.0 per cent.
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Sulphated ash
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Not more than 0.2 per cent.
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ASSAY
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99.0 - 101.0 % w/w calculated with reference to the dried substance.
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