Phenylpropanolamine Hydrochloride Oral Solution
»Phenylpropanolamine Hydrochloride Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of phenylpropanolamine hydrochloride (C9H13NO·HCl).
Packaging and storage— Preserve in tight containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparation,as obtained in the Assay.
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
Alcohol content(if present)á611ñ: between 90.0%and 110.0%of the labeled amount of C2H5OH.
Assay—
Solvent A,Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Phenylpropanolamine Hydrochloride Tablets.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 750mg of phenylpropanolamine hydrochloride,to a 200-mLvolumetric flask,dilute with methanol to volume,and mix.Transfer 1.0mLof this solution to a 10-mLvolumetric flask,dilute with methanol to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Phenylpropanolamine Hydrochloride Tablets.Calculate the quantity,in mg per mL,of phenylpropanolamine hydrochloride (C9H13NO·HCl)in the portion of Oral Solution taken by the formula:
2(C/V)(rU/rS),
in which Cis the concentration,in µg per mL,of USP Phenylpropanolamine 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.
Auxiliary Information— Staff Liaison:Daniel K.Bempong,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 1546
Pharmacopeial Forum:Volume No.30(1)Page 161
Phone Number:1-301-816-8143