Fluphenazine Hydrochloride Injection
» Fluphenazine Hydrochloride Injection is a sterile solution of Fluphenazine Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 110.0 percent of the labeled amount of fluphenazine hydrochloride (C22H26F3N3OS·2HCl).
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11—
USP Endotoxin RS.
USP Fluphenazine Hydrochloride RS.
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 Injection, 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 6 N sodium hydroxide, 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.”
Bacterial endotoxins 85— It contains not more than 166.7 USP Endotoxin Units per mg of fluphenazine hydrochloride.
pH 791: between 4.8 and 5.2.
Other requirements— It meets the requirements under Injections 1.
Assay— Proceed with Injection 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.
Senior Scientist
1-301-816-8330		 (MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2424