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.
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.
Assay—
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
1-301-816-8251
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 2196
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.