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Dicyclomine Hydrochloride IP/BP/USP Dicyclomine Hydrochloride is 2-diethylaminoethyl- bicyclohexyl-1-carboxylate hydrochloride
Formula: C19H35NO2, HCl
Category: Antispasmodic.
Mol. Wt.: 345.95
Dose: 30 to 60 mg daily, in divided doses. If used as an oral solution and the solution is required to be diluted, the diluted solution should be freshly prepared.
Analysis
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Specification
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Description
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White or almost white, crystalline powder; odourless or almost odourless.
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Solubility
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Freely soluble in ethanol (95%) and in chloroform; soluble in water; practically insoluble in ether.
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Identification:
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A:
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By infra-red absorption spectrum
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B:
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To 3 ml of a 0.1% w/v solution of sodium dodecyl sulphate, add 5 ml of chloroform and 0.05 ml of a 0.25% w/v solution of methylene blue, mix gently and allow to separate; the chloroform layer is blue. Add 20 mg of the substance being examined dissolved in 2 ml of water, mix gently and allow to separate; the aqueous layer is blue and the chloroform layer is colourless.
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| C: Chloride Test |
Dissolve 10 mg in 5 ml of water and add 0.2 ml of 2M nitric acid and 0.5 ml of silver nitrate solution; a white precipitate is produced.
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| D: Melts |
Between 172o and 174o.
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Related Substances
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Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).
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Sulphated Ash
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Not more than 0.1%.
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Loss on Drying
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Not more than 1.0%, determined on 1 g by drying in an oven at 105o
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Assay
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Dicyclomine Hydrochloride contains not less than 99.0 per cent and not more than 101.0 per cent of C19H35NO2,HCl, calculated with reference to the dried substance.
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