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Test |
Limits |
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Description
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A white crystalline powder
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Solubility
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Very soluble in water, freely soluble in alcohol, practically insoluble in ether.
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Identification
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A. Melting point 152°C to 155°C.
B. Absorbance ratio 275/282nm 1.15 to 1.20.
C. Infrared spectrophotometry as same as Atenolol CRS
D. TLC RF value of test and Atenolol CRS are the same.
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Appearance of 1% solution
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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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Optical rotation
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+0.10° to -0.10°
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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 0.25%, the sum of such
area not grater than 0.5%.
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Chlorides
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Not more than 0.1 per cent.
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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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