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PALAM PHARMA PVT. LTD.
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Dicyclomine Hydrochloride BP

Product Specification

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	Specification
Description	White or almost white, crystalline powder; odourless or almost odourless.
Solubility	Freely soluble in ethanol (95%) and in chloroform; soluble in water; practically insoluble in ether.
Identification:
A:	By infra-red absorption spectrum
B:	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.
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.
D: Melts	Between 172o and 174o.
Related Substances	Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).
Sulphated Ash	Not more than 0.1%.
Loss on Drying	Not more than 1.0%, determined on 1 g by drying in an oven at 105^o
Assay	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.

Product Code : 05

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PALAM PHARMA PVT. LTD.
GMP Certified Co.

12/C, Phase-1, Nr. Old Nirma, GIDC Estate, Vatva, Ahmedabad - 382445, Gujarat, India

Mr. Tarun Patel (Director)

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