Triflupromazine Oral Suspension, chemical structure, molecular formula, Reference Standards
Triflupromazine Oral Suspension
»Triflupromazine Oral Suspension contains an amount of triflupromazine (C18H19F3N2S)equivalent to not less than 90.0percent and not more than 110.0percent of the labeled amount of triflupromazine hydrochloride (C18H19F3N2S·HCl).
Packaging and storage
Preserve in tight,light-resistant glass containers.
USP Reference standards á11ñ
USP Triflupromazine 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.
Transfer about 1.0mLof Oral Suspension,accurately weighed,to a glass-stoppered,low-actinic 35-mLcentrifuge tube;add 10.0mLof methanol;and shake vigorously by mechanical means for 3minutes.Centrifuge for 5minutes,and use the methanol layer for the test.Apply 50µLof the test solution in streaks 4to 5cm in length and 0.2cm in width and 50µLof a Standard solution containing 1mg of USP Triflupromazine Hydrochloride RSper mLof methanol to a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel.Allow the streaks to dry,and develop the chromatogram in a solvent system consisting of a mixture of chloroform and methanol (4:1)until the solvent front has moved about four-fifths of the length of the plate.Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Locate the streaks by viewing the plate under short-wavelength and long-wavelength UVlight:the RFvalue and fluorescence of the streak obtained from the test solution correspond to those obtained from the Standard solution.
The UVabsorption spectrum of the solution employed for measurement of absorbance in the Assayexhibits maxima and minima at the same wavelengths as that of a similar solution of USP Triflupromazine Hydrochloride RS,concomitantly measured.
Uniformity of dosage units á905ñ
FOR ORAL SUSPENSION PACKAGED IN SNGLE-UNIT CONTAINERS:
meets the requirements.
Deliverable volume á698ñ
FOR ORAL SUSPENSION PACKAGED IN MULTIPLE-UNIT CONTAINERS:
meets the requirements.
Mix 25mLof isoamyl alcohol with 10mLof sodium hydroxide solution (1in 25)in a separator,shake,and discard the aqueous washing.Add 10mLof 0.1Nhydrochloric acid,shake,and discard the aqueous washing.Prepare 500mLof a 3in 100solution of the washed isoamyl alcohol in n-heptane.
Dissolve 1.4g of sodium acetate in 100mLof water,and adjust by the addition of glacial acetic acid to a pHof 5.6±0.1.
Transfer an accurately measured volume of well-mixed Oral Suspension,equivalent to about 20mg of triflupromazine hydrochloride,to a glass-stoppered,150-mLcentrifuge bottle.In a second,similar bottle dissolve about 20mg of USP Triflupromazine Hydrochloride RS,accurately weighed,in 1.0mLof water;then add 1.0mLof sodium hydroxide solution (1in 25);and mix.To a third,similar bottle add 2mLof water to provide the blank.Treat the two preparations and the blank as follows.Add 100.0mLof ether,shake by mechanical means for 15minutes,and allow the layers to separate.Transfer 50.0mLof the ether layer to another glass-stoppered,150-mLcentrifuge bottle,and evaporate on a water bath maintained at about 35,with the aid of a current of air,to dryness.Add 5.0mLof sodium hydroxide solution (1in 50),mix,add 100.0mLof Mixed solvent,shake by mechanical means for 10minutes,and centrifuge.Transfer 20.0mLof the nonaqueous phase to a glass-stoppered centrifuge tube,add 10.0mLof pH5.6Acetate buffer,shake by mechanical means for 5minutes,and centrifuge.Transfer 2.0mLof the nonaqueous phase to a glass-stoppered centrifuge tube containing 25.0mLof 0.5Nsulfuric acid,shake by mechanical means for 5minutes,and centrifuge.Concomitantly determine the absorbances of the aqueous solutions in 1-cm cells at the wavelength of maximum absorbance at about 255nm,with a suitable spectrophotometer,using the blank to set the instrument.Calculate the quantity,in mg,of triflupromazine hydrochloride (C18H19F3N2S·HCl)equivalent to the triflupromazine (C18H19F3N2S)in each mLof the Oral Suspension taken by the formula:
in which Wis the weight,in mg,of USP Triflupromazine Hydrochloride RStaken;Vis the volume,in mL,of Oral Suspension taken;and AUand ASare the absorbances of the solution from the Oral Suspension and the Standard solution,respectively.
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
Pharmacopeial Forum:Volume No.29(6)Page 1994
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