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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: 74°C to 79°C
B. Infrared spectrophotometry as same as Lidocaine hydrochloride CRS
C. Dried precipitate melts at about 230°C.
D. A green color is produced.
E. A bluish-green precipitate is formed.
F. It gives reaction of chlorides.
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Appearance of 5% solution
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Is clear and colorless.
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pH
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4.0 – 5.5
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2,6-Dimethylaniline
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Not more than 100 ppm.
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Heavy metals
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Not more than 5 ppm.
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Water
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5.5-7.0 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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