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Fluphenazine Enanthate Injection
»Fluphenazine Enanthate Injection is a sterile solution of Fluphenazine Enanthate in a suitable vegetable oil.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of fluphenazine enanthate (C29H38F3N3O2S).
Packaging and storage—
Preserve in single-dose or multiple-dose containers,preferably of Type Ior Type IIIglass,protected from light.
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—
To a volume of Injection,equivalent to about 50mg of fluphenazine enanthate,add 2mLof methanol and 3mLof palladium chloride solution (1in 1000):a rust-red color is produced.Add an excess of the palladium chloride solution:the color is intensified to a brownish red.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Dissolve an accurately measured volume of Injection,equivalent to about 150mg of fluphenazine enanthate,in 75mLof glacial acetic acid,add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 27.49mg of fluphenazine enanthate (C29H38F3N3O2S).
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 859
Phone Number:1-301-816-8330
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