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| Milen Ketoconazole |
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| Ketoconazole |
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| cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2- |
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| Pharmaceutical |
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Appearance : A white or almost white powder.
Solubility
A) Water : Practically insoluble.
B) Methylene : Freely soluble.
C) Methanol : Soluble.
D) Alcohol : Sparingly soluble.
Idendification
A) Melting Point : 148 - 152 'C
B) FT - IR : Examine by infrared absorption spectrum, comparing with the reference standard spectrum.
C) HPTLC : The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with standard solution ( a ).
D) Chloride (a) Test : The solution gives reaction ( a ) of chloride.
Appearance of Solution : Solution S is clear and not more intensely coloured than ref. solution BY4.
Optical Rotation : - 0.10 to + 0.10 o
Related Substances : Max. 0.5 %
Heavy Metals : Max. 20 ppm
Loss On Drying : Max. 0.5 %
Sulphated Ash : Max. 0.1 %
Organic Volatile Impurities
A) Methanol : Max. 500 ppm
B) Methylene Chloride : Max. 600 ppm
C) Ethyl Acetate : Max. 1000 ppm
D) Benzene : Max. 2 ppm
E) Toluene : Max. 890 ppm
Assay : 99.0 - 101.0 % |
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