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Test |
Limits |
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Description
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A white or slightly yellow, crystalline powder.
It shows polymorphism.
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Solubility
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Practically insoluble in water, soluble in methylene chloride, slightly soluble in ethanol
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Identification
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A. UV spectrum is as same as Piroxicam CRS.
B. Infrared spectrophotometry as same as Piroxicam CRS.
C. TLC RF value of test and Piroxicam CRS are the same.
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Appearance of solution
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10% solution is clear and not more intensely colored than intensity 6 of the range of
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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 0.2%, the sum of such
area not grater than 0.4%.
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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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98.5 - 101.0 % w/w calculated with reference to the dried substance.
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