FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

(Official January 1, 2007)

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: 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.