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Limits |
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Description
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A white or pale yellow, crystalline powder.
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Solubility
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Practically insoluble in water, soluble in methylene chloride, slightly soluble in acetone and in alcohol. It dissolves in dilute solutions of alkali hydroxides.
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Identification
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A. UV max at 258nm and 334nm, absorption ratio at 258/334 nm is 2.2 to 2.4.
B. Infrared spectrophotometry as same as Nalidixic acid CRS
C. TLC RF value of test and Nalidixic acid CRS are the same.
D. An orange-red color develops
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Melting point
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225°C - 231°C.
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Absorbance
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3% solution at 420 nm is not greater than 0.10-absorbance unit.
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Related substances TLC
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The area of any spot apart from the principle peak is not grater than 0.04%, the sum of such spot not grater than 0.1%.
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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 0.5 per cent
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Sulphated ash
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Not more than 0.1 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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