Fluphenazine Hydrochloride Injection
»Fluphenazine Hydrochloride Injection is a sterile solution of Fluphenazine Hydrochloride in Water for Injection.It contains not less than 95.0percent and not more than 110.0percent of the labeled amount of fluphenazine hydrochloride (C22H26F3N3OS·2HCl).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
USP Reference standards á11ñ— 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 10mg of fluphenazine hydrochloride,to a separator,and to a second separator transfer 10mg of USP Fluphenazine Hydrochloride RS.To each separator add 20mLof 6Nsodium hydroxide,and extract each mixture with 20mLof isooctane.Evaporate the isooctane solutions to dryness,and proceed as directed in the Identificationtest under Fluphenazine Hydrochloride Tablets,beginning with “dissolve the residues in 0.5-mLportions.”
Bacterial endotoxins á85ñ— It contains not more than 166.7USP Endotoxin Units per mg of fluphenazine hydrochloride.
pHá791ñ: between 4.8and 5.2.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Proceed with Injection as directed in the Assayunder Fluphenazine Hydrochloride Elixir.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 860
Phone Number:1-301-816-8330