Packaging and storage— Preserve in tight containers, protected from light.

Labeling— Label it to indicate that it is to be diluted to appropriate strength with water or other suitable fluid prior to administration.

USP Reference standards 11— USP Fluphenazine Hydrochloride RS.

Identification— Transfer a volume of Oral Solution, equivalent to about 10 mg of fluphenazine hydrochloride, to a separator, and to a second separator transfer 10 mg of USP Fluphenazine Hydrochloride RS. To each separator add 20 mL of sodium hydroxide solution (1 in 4), and extract each mixture with 20 mL of isooctane. Evaporate the isooctane solutions to dryness, and proceed as directed in the Identification test under Fluphenazine Hydrochloride Tablets, beginning with “dissolve the residues in 0.5-mL portions.”

pH 791: between 4.0 and 5.0.

Alcohol content 611: not less than 90.0% and not more than 110.0% of the labeled amount, the labeled amount being not more than 15.0% of C2H5OH.

Residual solvents 467: meets the requirements.

Assay— Proceed with Oral Solution as directed in the Assay under Fluphenazine Hydrochloride Elixir.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 950

Phone Number : 1-301-816-8330