Pseudoephedrine Hydrochloride, Carbinoxamine Maleate, and Dextromethorphan Hydrobromide Oral Solution
» Pseudoephedrine Hydrochloride, Carbinoxamine Maleate, and Dextromethorphan Hydrobromide Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of carbinoxamine maleate (C16H19ClN2O·C4H4O4), dextromethorphan hydrobromide (C18H25NO·HBr), and pseudoephedrine hydrochloride (C10H15NO·HCl).
Packaging and storage—
Preserve in tight, light-resistant containers, and store at controlled room temperature.
USP Reference standards 
11
—
11—
USP Carbinoxamine Maleate RS 
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USP Dextromethorphan Hydrobromide RS
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USP Pseudoephedrine Hydrochloride RS
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Identification—
A:
The retention times of the carbinoxamine maleate and dextromethorphan hydrobromide peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay for carbinoxamine maleate and dextromethorphan hydrobromide.
B:
The retention time of the pseudoephedrine hydrochloride peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for pseudoephedrine hydrochloride.
Microbial enumeration tests 61 and Tests for specified microorganisms 62—
The total aerobic microbial count does not exceed 100 per g, the total combined molds and yeasts count does not exceed 10 per g, and it meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
61 and Tests for specified microorganisms 62—
The total aerobic microbial count does not exceed 100 per g, the total combined molds and yeasts count does not exceed 10 per g, and it meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Uniformity of dosage units 905—
905—
for oral solution packaged in single-unit containers:
meets the requirements.
Deliverable volume 698—
698—
for oral solution packaged in multiple-unit containers:
meets the requirements.
pH 791:
between 3.0 and 5.0.
791:
between 3.0 and 5.0.
Alcohol content, Method II 611 (if present):
between 90.0% and 110.0% of the labeled amount of C2H5OH is found.
611 (if present):
between 90.0% and 110.0% of the labeled amount of C2H5OH is found.
Assay for carbinoxamine maleate and dextromethorphan hydrobromide—
pH 5.5 buffer—
Dissolve about 4.4 g of dibasic potassium phosphate in 1000 mL of water. Adjust with phosphoric acid to a pH of 5.5.
Mobile phase—
Prepare a filtered and degassed mixture of methanol and pH 5.5 buffer (60:40). Make adjustments if necessary (see System Suitability under Chromatography 621).
621).
Standard preparation—
Dissolve accurately weighed quantities of USP Carbinoxamine Maleate RS and USP Dextromethorphan Hydrobromide RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having known concentrations of about 0.1 mg per mL of carbinoxamine maleate and 0.3 mg per mL of dextromethorphan hydrobromide.
Assay preparation—
Transfer an accurately measured volume of Oral Solution to a volumetric flask, and dilute with water to volume to obtain a solution having concentrations of about 0.1 mg per mL of carbinoxamine maleate and 0.3 mg per mL of dextromethorphan hydrobromide, and mix.
Chromatographic system (see Chromatography 621)—
The liquid chromatograph is equipped with a 225-nm detector and a 4.6-mm × 25-cm column that contains packing L9. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative retention times are about 0.8 for dextromethorphan and 1.0 for carbinoxamine; the resolution, R, between carbinoxamine and dextromethorphan is not less than 3.0; the tailing factor for the dextromethorphan peak is not more than 2.0; and the relative standard deviation for replicate injections is not more than 2.0%.
621)—
The liquid chromatograph is equipped with a 225-nm detector and a 4.6-mm × 25-cm column that contains packing L9. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative retention times are about 0.8 for dextromethorphan and 1.0 for carbinoxamine; the resolution, R, between carbinoxamine and dextromethorphan is not less than 3.0; the tailing factor for the dextromethorphan peak 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 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the analyte peaks. Calculate the quantities, in mg, of carbinoxamine maleate (C16H19ClN2O·C4H4O4) and dextromethorphan hydrobromide (C18H25NO·HBr) in each mL in the volume of Oral Solution taken by the formula:
C(VD)(rU / rS)
in which C is the concentration, in mg per mL, of the appropriate Reference Standard in the Standard preparation; V is the volume of Oral Solution taken; D is the dilution factor used for the Assay preparation; and rU and rS are the peak responses for the appropriate analyte obtained from the Assay preparation and the Standard preparation, respectively.
Assay for pseudoephedrine hydrochloride—
pH 5.5 buffer and Mobile phase—
Proceed as directed in the Assay for carbinoxamine maleate and dextromethorphan hydrobromide.
Standard preparation—
Dissolve an accurately weighed quantity of USP Pseudoephedrine Hydrochloride RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having a known concentration of about of 1.2 mg per mL of pseudoephedrine hydrochloride.
Assay preparation—
Transfer an accurately measured volume of Oral Solution to a volumetric flask, dilute with water to volume to obtain a solution having a concentration of about 1.2 mg per mL of pseudoephedrine hydrochloride, and mix.
Chromatographic system (see Chromatography 621)—
The liquid chromatograph is equipped with a 257-nm detector and a 4.6-mm × 25-cm column that contains packing L9. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency is not less than 1000 theoretical plates; and the relative standard deviation for replicate injections is not more than 2.0%.
621)—
The liquid chromatograph is equipped with a 257-nm detector and a 4.6-mm × 25-cm column that contains packing L9. The flow rate is about 1.5 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency is not less than 1000 theoretical plates; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure—
Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the analyte peaks. Calculate the quantity, in mg, of pseudoephedrine hydrochloride (C10H15NO·HCl) in each mL in the volume of Oral Solution taken by the formula:
C(VD)(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 of Oral Solution taken; D is the dilution factor used for the Assay preparation; and rU and rS are the peak responses for pseudoephedrine hydrochloride 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 |
|
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4480
Pharmacopeial Forum: Volume No. 30(1) Page 173