Hyoscyamine Sulfate Oral Solution
» Hyoscyamine Sulfate Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of hyoscyamine sulfate [(C17H23NO3)2·H2SO4·2H2O].
Packaging and storage Preserve in tight, light-resistant containers, and store at controlled room temperature.
USP Reference standards 11
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, 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 3.0 and 6.5.
Diluent, Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Hyoscyamine Sulfate Injection.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 0.5 mg of hyoscyamine sulfate, to a 100-mL volumetric flask, dilute with Diluent to volume, and mix. Pass an aliquot through a 0.45-µm filter, discarding the first 5 mL of the filtrate.
Procedure Separately inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the area responses for the major peaks. Calculate the quantity, in mg, of hyoscyamine sulfate [(C17H23NO3)2·H2SO4·2H2O] in each mL of the Oral Solution taken by the formula:
100 × 1.053 × (C/V)(rU / rS)in which 1.053 is the ratio of the molecular weight of hydrated hyoscyamine sulfate to that of anhydrous hyoscyamine sulfate; C is defined under Standard preparation; V is the volume, in mL, of Oral Solution taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3466Pharmacopeial Forum: Volume No. 31(5) Page 1373