Docusate Sodium Solution
» Docusate Sodium Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C20H37NaO7S.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
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.
pH 791: between 4.5 and 6.9.
Mobile phase, Diluent, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Docusate Sodium Capsules.
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 C20H37NaO7S 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.
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USP35NF30 Page 2960