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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 % |
Industrial field |
additive, pharmaceutical |
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