Pseudoephedrine Hydrochloride Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Pseudoephedrine Hydrochloride Syrup)
»Pseudoephedrine Hydrochloride Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of pseudoephedrine hydrochloride (C10H15NO·HCl).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— Extract a volume of Oral Solution,equivalent to about 120mg of pseudoephedrine hydrochloride,with two 30-mLportions of ether,discard the extracts,and add 4mLof 1Nsodium hydroxide.Extract with 30mLof chloroform,and evaporate the chloroform on a steam bath,avoiding overheating:the pseudoephedrine so obtained melts at about 118,the procedure for Class Ibeing used (see Melting Range or Temperature á741ñ),and when 50mg is dissolved in 10mLof 0.1Nhydrochloric acid,the resulting solution is dextrorotatory.
Reaction— It is acid to litmus.
Add the following:
Uniformity of dosage units á905ñ—
FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.USP28
Add the following:
Deliverable volume á698ñ—
FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.USP28
Assay—
Mobile phase— Prepare a filtered and degassed mixture of alcohol and 0.40%ammonium acetate solution (17:3).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Dissolve an accurately weighed quantity of USP Pseudoephedrine Hydrochloride RSin 0.01Nhydrochloric acid to obtain a solution having a known concentration of about 1.2mg per mL.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 60mg of pseudoephedrine hydrochloride,to a 50-mLvolumetric flask,dilute with 0.01Nhydrochloric acid to volume,mix,and filter.
Chromatographic system (see Chromatography á621ñ)— 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 1.5mLper minute.Chromatograph five replicate injections of the Standard preparation,and record the peak responses as directed forProcedure: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 10µL)of the Standard preparationand the Assay preparationinto 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 mLof the Oral Solution taken by the formula:
50(C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Pseudoephedrine Hydrochloride RSin the Standard preparation;Vis the volume,in mL,of Oral Solution taken;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
(Official June 1,2005)
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1672
Pharmacopeial Forum:Volume No.30(1)Page 172
Phone Number:1-301-816-8143