Fluphenazine Hydrochloride Oral Solution
» Fluphenazine Hydrochloride Oral Solution is an aqueous solution of Fluphenazine Hydrochloride. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of fluphenazine hydrochloride (C22H26F3N3OS·2HCl).
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 Click to View Structure
[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. ]
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.
Assay— Proceed with Oral Solution as directed in the Assay under Fluphenazine Hydrochloride Elixir.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 3252