PRODUCT : DOCUSATE SODIUM USP (WAX form)

    Batch No     :  DS20710                                                         Mfg. Date  :  FEB - 2013

    Sample Qty : 500 Kgs                                                           Exp. Date  :  FEB - 2016

Sl.No

TESTS

SPECIFICATIONS

RESULT

01.

Description

White, wax like, plastics solid, having a characteristic odor.

Complies

02.

Clarity of solution

25 gms in  100 ml alcohol as per USP

Complies

03.

Solubility

Sparingly soluble in water, very soluble in solvent hexane, freely soluble alcohol and in glycerin

Complies

04.

Identification by IR

To be concordant with the Working standard Spectrum shall comply

Complies

05.

Moisture content by KF

Not more than  2.0%

1.6%

06.

Residue on ignition

Between 15.5%  and 16.5%

16.22%

07.

Heavy Metals

NMT 0.001%

Less than  0.001%

08.

Limit of Bis(2-ethylhexyl) Maleate.

Not more than  0.4%

0.02%

09.

Assay on anhydrous basis

( By titrimetry)

Not less than  99.0%  and Not more than  100.5% 

99.52%

10.

Residual Solvents

1)      Methanol

Not more than  200   ppm

5.9 ppm