Trifluoperazine Hydrochloride Injection
»Trifluoperazine Hydrochloride Injection is a sterile solution of Trifluoperazine Hydrochloride in Water for Injection.It contains an amount of trifluoperazine hydrochloride (C21H24F3N3S·2HCl)equivalent to not less than 90.0percent and not more than 110.0percent of the labeled amount of trifluoperazine (C21H24F3N3S).
Packaging and storage— Preserve in multiple-dose containers,preferably of Type Iglass,protected from light.
NOTE— Throughout the following procedures,protect test or assay specimens,the Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
Identification—
A: The solution employed for measurement of absorbance in the Assayexhibits UVmaxima and minima at the same wavelengths as that of a similar solution of USP Trifluoperazine Hydrochloride RS,concomitantly measured.
B: Mix 5mLof it with 5mLof methanol:a 5-µLportion of this solution responds to Identificationtest Dunder Trifluoperazine Hydrochloride.
Bacterial endotoxins á85ñ— It contains not more than 172.0USP Endotoxin Units per mg of trifluoperazine.
pHá791ñ: between 4.0and 5.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— [NOTE—Use low-actinic glassware.]Transfer an accurately measured volume of Injection,equivalent to about 20mg of trifluoperazine,to a 250-mLseparator.Add 10mLof 4Nsulfuric acid,and extract with three 25-mLportions of carbon tetrachloride.Discard the carbon tetrachloride after each extraction.Add 10mLof ammonium hydroxide,and extract with five 40-mLportions of cyclohexane.Extract the combined cyclohexane extracts with five 50-mLportions of 0.1Nhydrochloric acid,collecting the aqueous extracts in a 500-mLvolumetric flask.Dilute with 0.1Nhydrochloric acid to volume,and mix.Transfer 25.0mLof this solution to a 100-mLvolumetric flask,dilute with 0.1Nhydrochloric acid to volume,and mix.Concomitantly determine the absorbances of this solution and of a Standard solution of USP Trifluoperazine Hydrochloride RSin the same medium having a known concentration of about 12µg per mLin 1-cm cells at 278nm and at the maximum at about 255nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of trifluoperazine (C21H24F3N3S)in each mLof the Injection taken by the formula:
(407.51/480.43)(2C/V)(A255-A278)U/(A255-A278)S,
in which 407.51and 480.43are the molecular weights of trifluoperazine and trifluoperazine hydrochloride,respectively,Cis the concentration,in µg per mL,of USP Trifluoperazine Hydrochloride RSin the Standard solution,Vis the volume,in mL,of Injection taken,and the parenthetic expressions are the differences in the absorbances of the two solutions at the wavelengths indicated by the subscripts,for the assay solution (U)and the Standard solution (S),respectively.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1975
Phone Number:1-301-816-8330