Isosorbide Oral Solution, chemical structure, molecular formula, Reference Standards

Isosorbide Oral Solution

»Isosorbide Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of isosorbide (C6H10O4).

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Isosorbide RS.

Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatograms of the Standard preparations,as obtained in the Assay.

Uniformity of dosage units á905ñ—

FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume á698ñ—

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

pHá791ñ: between 3.2and 3.8.

Assay—

Internal standard solution,Standard solution,Standard preparations,Chromatographic system,and System suitabilityand standard curve— Proceed as directed in the Assayunder Isosorbide Concentrate.

Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 450mg of isosorbide,to a 250-mLvolumetric flask,add 25.0mLof Internal standard solution,then add water to volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Isosorbide Concentrate.Calculate the quantity,in mg,of isosorbide (C6H10O4)in each mLof the Oral Solution taken by the formula:

250(C/V),

in which Cis the concentration,in mg per mL,of isosorbide in the Assay preparationfound by reference to the Standard curve;and Vis the volume,in mL,of Oral Solution taken.

Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate

Expert Committee:(PA5)Pharmaceutical Analysis 5

USP28–NF23Page 1085

Pharmacopeial Forum:Volume No.29(6)Page 1913

Phone Number:1-301-816-8305