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Fluphenazine Hydrochloride Oral Solution
»Fluphenazine Hydrochloride Oral Solution is an aqueous solution of Fluphenazine Hydrochloride.It contains not less than 90.0percent and not more than 110.0percent 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 á11ñ—
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 Oral Solution,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 sodium hydroxide solution (1in 4),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.”
pHá791ñ:
between 4.0and 5.0.
Alcohol content á611ñ:
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.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 861
Phone Number:1-301-816-8330
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