Pseudoephedrine Hydrochloride Oral Solution
» Pseudoephedrine Hydrochloride Oral Solution contains 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, light-resistant containers.
USP Reference standards 11
USP Pseudoephedrine Hydrochloride RS
Identification— Extract a volume of Oral Solution, equivalent to about 120 mg of pseudoephedrine hydrochloride, with two 30-mL portions of ether, discard the extracts, and add 4 mL of 1 N sodium hydroxide. Extract with 30 mL of chloroform, and evaporate the chloroform on a steam bath, avoiding overheating: the pseudoephedrine so obtained melts at about 118, the procedure for Class I being used (see Melting Range or Temperature 741), and when 50 mg is dissolved in 10 mL of 0.1 N hydrochloric acid, the resulting solution is dextrorotatory.
Reaction— It is acid to litmus.
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.
Mobile phase— Prepare a filtered and degassed mixture of alcohol and 0.40% ammonium acetate solution (17:3). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Pseudoephedrine Hydrochloride RS in 0.01 N hydrochloric acid to obtain a solution having a known concentration of about 1.2 mg per mL.
Assay preparation— Transfer an accurately measured volume of Oral Solution, equivalent to about 60 mg of pseudoephedrine hydrochloride, to a 50-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, mix, and filter.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 254-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 five replicate injections of the Standard preparation, 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— 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 each mL of the Oral Solution taken by the formula:
50(C/V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Pseudoephedrine Hydrochloride RS in the 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.
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
USP32–NF27 Page 3439
Pharmacopeial Forum: Volume No. 30(1) Page 172
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.