Pseudoephedrine Hydrochloride Extended-Release Capsules
» Pseudoephedrine Hydrochloride Extended-Release Capsules contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of pseudoephedrine hydrochloride (C10H15NO·HCl).
Packaging and storage Preserve in tight containers.
USP Reference standards 11
A: A portion of Capsule contents, equivalent to about 180 mg of pseudoephedrine hydrochloride, meets the requirements of Identification test A under Pseudoephedrine Hydrochloride Extended-Release Tablets.
B: 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.
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Times: 3, 6, and 12 hours.
Procedure Determine the amount of C10H15NO·HCl dissolved, employing the procedure set forth in the Assay, using a filtered portion of the solution under test as the Assay preparation in comparison with a Standard solution having a known concentration of USP Pseudoephedrine Hydrochloride RS in the same Medium.
Tolerances The percentages of the labeled amount of C10H15NO·HCl dissolved at the times specified conform to Acceptance Table 2.
Uniformity of dosage units 905: meet the requirements.
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Pseudoephedrine Hydrochloride Extended-Release Tablets.
Assay preparation Remove, as completely as possible, the contents of not fewer than 20 Capsules, weigh, and mix. Transfer an accurately weighed portion of the combined contents, equivalent to about 120 mg of pseudoephedrine hydrochloride, to a 100-mL volumetric flask, add 10 mL of 0.01 N hydrochloric acid, and sonicate for 10 minutes. Cool to room temperature. Dilute with 0.01 N hydrochloric acid to volume, mix, and filter.
Procedure Proceed as directed in the Assay under Pseudoephedrine Hydrochloride Extended-Release Tablets. Calculate the quantity, in mg, of pseudoephedrine hydrochloride (C10H15NO·HCl) in the portion of Capsules taken by the formula:
100C(rU / rS)in which C is the concentration, in mg per mL, of USP Pseudoephedrine Hydrochloride RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4477Pharmacopeial Forum: Volume No. 31(1) Page 181