A: Aportion of Capsule contents,equivalent to about 180mg of pseudoephedrine hydrochloride,meets the requirements of Identificationtest Aunder Pseudoephedrine Hydrochloride Extended-Release Tablets.

B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.

Medium: water;900mL.

Apparatus 2: 50rpm.

Times: 3,6,and 12hours.

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 preparationin comparison with a Standard solution having a known concentration of USP Pseudoephedrine Hydrochloride RSin the same Medium.

Tolerances— The percentages of the labeled amount of C10H15NO·HCl dissolved at the times specified conform to Acceptance Table 1.

Mobile phase,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Pseudoephedrine Hydrochloride Extended-Release Tablets.

Assay preparation— Remove,as completely as possible,the contents of not fewer than 20Capsules,weigh,and mix.Transfer an accurately weighed portion of the combined contents,equivalent to about 120mg of pseudoephedrine hydrochloride,to a 100-mLvolumetric flask,add 10mLof 0.01Nhydrochloric acid,and sonicate for 10minutes.Cool to room temperature.Dilute with 0.01Nhydrochloric acid to volume,mix,and filter.

Procedure— Proceed as directed in the Assayunder Pseudoephedrine Hydrochloride Extended-Release Tablets.Calculate the quantity,in mg,of pseudoephedrine hydrochloride (C10H15NO·HCl)in the portion of Capsules taken by the formula: in which Cis the concentration,in mg per mL,of USP Pseudoephedrine Hydrochloride RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.