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Docusate Sodium

Bulk Active : Docusate Sodium
Pharmacologic Activity : Laxative
CAS No : 577-11-7
Specifications : BP/EP/USP
Regulatory compliance : eDMF(CTD)

TEST USP 36 BP 2013/EP 7.4
CHARACTERS White, wax-like, plastic solid, having a characteristic odor suggestive of
octyl alcohol, but no odor of other solvents
White or almost white, waxy masses
or flakes, hygroscopic
SOLUBILITY Very soluble in solvent hexane; freely soluble in alcohol and in glycerin; sparingly soluble in water. Sparingly soluble in water, freely soluble in ethanol 96% and in methylene chloride.




The infrared absorption spectrum should be concordant with USP. reference spectrum of Docusate sodium.


Infrared absorption spectrum of sample should be concordant with the Ph. Eur reference spectrum of Docusate Sodium

Gives reaction for sodium

Clarity of solution Solution (25gm in 100ml alcohol) should not develop a haze within 24 hrs ------
Alkalinity ----- Not more than 0.2 ml of 0.1 M
hydrochloric acid is required to change the
colour of the indicator to red
Related Non-ionic substances ----- NMT 0.4 per cent.
Limit of bis ( 2-ethylhexyl) maleate NMT 0.4 %. -----
Chlorides ----- Maximum 350 ppm
Water Not more than 2.0 %. Maximum 3.0 per cent.
Sodium sulphate
Maximum 2%
RESIDUE ON IGNITION Between 15.5% and 16.5%, calculated on anhydrous basis -----
HEAVY METALS Not more than 10 ppm Maximum 10 ppm
ASSAY NLT 99.0% and NMT 100.5% of C20H37NaO7S, calculated on the anhydrous basis. 98.0% to 101.0% per cent of C20H37NaO7S calculated on anhydrous substance.