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Test |
Limits |
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Description
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A white TO slightly yellow powder.
It shows polymorphism.
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Solubility
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Practically insoluble in water, in alcohol, in ether and in methylene chloride.
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Identification
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A. UV absorption maximum, at 247 nm and 312 nm, the specific absorbances at these maximum are 940 to 1040 and 485 to 535, respectively.
B. Infrared spectrophotometry as same as Mebendazol CRS.
C. An intense yellow color is produced.
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Related substances TLC
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Any other spot other than main spot not more intensely than 0.25% and the sum spot other than main spot not more than 0.5%.
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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 percent
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Sulphated ash
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Not more than 0.1 percent.
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ASSAY
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98.0 - 102.0 % w/w calculated with reference to the dried substance.
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