Phenylpropanolamine Hydrochloride Oral Solution
» Phenylpropanolamine Hydrochloride Oral Solution contains not less than 90.0 percent and not more than 110.0 percent 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 preparation corresponds to that of the Standard preparation, as obtained in the Assay.
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.
Alcohol content (if present) 611: between 90.0% and 110.0% of the labeled amount of C2H5OH.
Solvent A, Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Phenylpropanolamine Hydrochloride Tablets.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 750 mg of phenylpropanolamine hydrochloride, to a 200-mL volumetric flask, dilute with methanol to volume, and mix. Transfer 1.0 mL of this solution to a 10-mL volumetric flask, dilute with methanol to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under 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 C is the concentration, in µg per mL, of USP Phenylpropanolamine 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.
USP32NF27 Page 3289Pharmacopeial Forum: Volume No. 30(1) Page 161