Identification—
The retention time of the docusate sodium peak in the chromatogram of the
Assay preparation corresponds to that of the docusate sodium peak in the chromatogram of the
Standard preparation, as obtained in the
Assay.
Assay—
Assay preparation—
Transfer an accurately measured volume of Solution, equivalent to about 100 mg of docusate sodium, to a 100-mL volumetric flask, dilute with Diluent to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with Diluent to volume, and mix. Pass this solution through a filter into a vial, discarding the first 6 mL of the filtrate.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Docusate Sodium Capsules. Calculate the quantity, in mg, of C
20H
37NaO
7S in each mL of the Solution taken by the formula:
1000(C / V)(rU / rS),
in which
V is the volume, in mL, of Solution taken; and the other terms are as defined therein.
791
:
between 4.5 and 6.9.