NOTE—Throughout the following procedures, protect test or assay specimens, the USP Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.

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

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

(Official January 1, 2007)

Diluent solution, Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Fluphenazine Hydrochloride.

Assay preparation— Using a “to contain” pipet transfer a volume of Elixir, equivalent to about 6 mg of fluphenazine hydrochloride, to a 100-mL volumetric flask. Rinse the pipet with Diluent solution to complete the transfer, dilute with Diluent solution to volume, and mix. Filter, discarding the first 5 mL of the filtrate.

Procedure— Separately inject equal volumes (about 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of fluphenazine hydrochloride (C22H26F3N3OS·2HCl) in each mL of the Elixir taken by the formula: in which C is the concentration, in mg per mL, of USP Fluphenazine Hydrochloride RS in the Standard preparation; V is the volume, in mL, of Elixir taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.