Pseudoephedrine Hydrochloride Tablets

» Pseudoephedrine Hydrochloride Tablets 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.

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USP Pseudoephedrine Hydrochloride RS

Identification—

A: Thin-Layer Chromatographic Identification Test

201

—

Test solution— Transfer 1 tablet to a glass-stoppered tube, add 10 mL of water, and shake or mix until the tablet completely disintegrates. Sonicate for 5 minutes, centrifuge for 5 minutes, and pass through a nylon filter.

Standard solution— Dissolve an accurately weighed quantity of USP Pseudoephedrine Hydrochloride RS in water to obtain a solution having a known concentration of about 3 mg per mL.

Developing solvent system— Prepare a mixture of butyl alcohol, glacial acetic acid, and water (8:2:2).

Procedure— Proceed as directed in the chapter. The RF value and appearance of the principal spot obtained from the Test solution correspond to that obtained from the Standard solution.

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

Dissolution, Procedure for a Pooled Sample

711

—

Medium: water; 900 mL.

Apparatus 2: 50 rpm.

Time: 45 minutes.

Determine the amount of C10H15NO·HCl dissolved by employing the following method.

Mobile phase— Proceed as directed in the Assay.

Chromatographic system (see Chromatography

621

)— The liquid chromatograph is equipped with a 214-nm detector and a 4.6-mm × 25-cm column that contains packing L3. The flow rate is about 1.5 mL per minute. Chromatograph the Standard solution, and record the peak responses as directed for Procedure: the tailing factor is not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%.

Procedure— Inject a volume of a filtered portion of the solution under test into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity of C10H15NO·HCl dissolved in comparison with a Standard solution having a known concentration of USP Pseudoephedrine Hydrochloride RS in the same medium and similarly chromatographed.

Tolerances— Not less than 75% (Q) of the labeled amount of C10H15NO·HCl is dissolved in 45 minutes.

Uniformity of dosage units

905

: meet the requirements, the following method being employed for chewable tablets.

procedure for content uniformity—

Mobile phase and Chromatographic system— Proceed as directed in the Assay under Pseudoephedrine Hydrochloride Oral Solution.

Standard preparation— Dissolve an accurately weighed quantity of USP Pseudoephedrine Hydrochloride RS in a mixture of 0.01 N hydrochloric acid and methanol (4:1) to obtain a solution having a known concentration of about 0.15 mg per mL.

Test preparation— Transfer 1 Tablet, accurately weighed, into a 100-mL volumetric flask, add 20 mL of methanol, and shake for 30 minutes. Add about 25 mL of 0.01 N hydrochloric acid, and sonicate to dissolve. Cool to room temperature, dilute with 0.01 N hydrochloric acid to volume, mix, and filter.

Procedure— Proceed as directed in the Assay.

Assay—

Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Pseudoephedrine Hydrochloride Oral Solution.

Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 120 mg of pseudoephedrine hydrochloride, to a 100-mL volumetric flask, add 0.01 N hydrochloric acid, and sonicate to dissolve. Cool to room temperature. Dilute with 0.01 N hydrochloric acid to volume, mix, and filter.

Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of pseudoephedrine hydrochloride (C10H15NO·HCl) in the portion of Tablets 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. Senior Scientific Liaison 1-301-816-8139	(SM22010) Monographs - Small Molecules 2
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org
711	Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106	(GCDF2010) General Chapters - Dosage Forms

USP35–NF30 Page 4478

Pharmacopeial Forum: Volume No. 30(1) Page 172