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
USP Pseudoephedrine Hydrochloride RS
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.
Dissolution 711
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.
Time (hours) Amount dissolved
3 between 20% and 50%
6 between 45% and 75%
12 not less than 75%
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3438
Pharmacopeial Forum: Volume No. 31(1) Page 181
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.