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Test |
Limits |
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Description
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A white or almost white, crystalline powder
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Solubility
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Practically insoluble in water, very soluble in alcohol and in methylene chloride, freely soluble in ether.
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Identification
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A. Melting point: 66°C to 70°C
B. Infrared spectrophtometry as same as lidocaine base CRS
C. Dried precipitate melts at about 230°C, with decomposition.
D. A green color is produced.
E. A bluish-green precipitate is formed.
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Appearance of 10%solution
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Is clear and colorless.
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2,6-Dimethylaniline
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Not more than 100 ppm.
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Chlorides
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Not more than 35 ppm.
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Sulphates
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Not more than 0.1 per cent.
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Heavy metals
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Not more than 20 ppm.
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Water
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Not more than 1.0 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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