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.
noteThroughout 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.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 2424