Docusate Sodium Solution, chemical structure, molecular formula, Reference Standards

Docusate Sodium Solution

»Docusate Sodium Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C20H37NaO7S.

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Docusate Sodium RS.

Identification— The retention time of the docusate sodium peak in the chromatogram of the Assay preparationcorresponds to that of the docusate sodium peak in the chromatogram of the Standard preparation,as obtained in the Assay.

pHá791ñ: between 4.5and 6.9.

Assay—

Mobile phase,Diluent,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Docusate Sodium Capsules.

Assay preparation— Transfer an accurately measured volume of Solution,equivalent to about 100mg of docusate sodium,to a 100-mLvolumetric flask,dilute with Diluentto volume,and mix.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,dilute with Diluentto volume,and mix.Pass this solution through a filter into a vial,discarding the first 6mLof the filtrate.

Procedure— Proceed as directed for Procedurein the Assayunder Docusate Sodium Capsules.Calculate the quantity,in mg,of C20H37NaO7Sin each mLof the Solution taken by the formula:

1000(C/V)(rU/rS),

in which Vis the volume,in mL,of Solution taken;and the other terms are as defined therein.

Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 686

Phone Number:1-301-816-8251