Isosorbide Oral Solution
» Isosorbide Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of isosorbide (C6H10O4).
Packaging and storage Preserve in tight containers.
USP Reference standards 11
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatograms of the Standard preparations, as obtained in the Assay.
Uniformity of dosage units 905
for oral solution packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral solution packaged in multiple-unit containers: meets the requirements.
pH 791: between 3.2 and 3.8.
Internal standard solution, Standard solution, Standard preparations, Chromatographic system, and System suitability and standard curve Proceed as directed in the Assay under Isosorbide Concentrate.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 450 mg of isosorbide, to a 250-mL volumetric flask, add 25.0 mL of Internal standard solution, then add water to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Isosorbide Concentrate. Calculate the quantity, in mg, of isosorbide (C6H10O4) in each mL of the Oral Solution taken by the formula:
250(C/V)in which C is the concentration, in mg per mL, of isosorbide in the Assay preparation found by reference to the Standard curve; and V is the volume, in mL, of Oral Solution taken.
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USP35NF30 Page 3586Pharmacopeial Forum: Volume No. 29(6) Page 1913