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Test |
Limits |
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Description
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A white or almost white powder.
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Solubility
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Soluble in water and alcohol.
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Identification
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A. Infrared spectrophotometry as same as Propranolol CRS
B. TLC RF value of test and Propranolol CRS are the same.
C. It gives reaction of chlorides
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Melting point
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163°C - 166°C.
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Appearance of solution
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10% solution Is clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color
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Acidity or alkalinity
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To 1% solution Add 0.2 ml of methyl red solution and 0.2 ml of 0.01M hydrochloric acid. The solution is red. Add 0.4 ml of 0.01M sodium hydroxide. The solution is yellow.
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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 0.1%, 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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Specific rotation
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-1.0 to +1.0
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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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