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Triflupromazine Hydrochloride Tablets
»Triflupromazine Hydrochloride Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C18H19F3N2S·HCl.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
USP Reference standards á11ñ—
USP Triflupromazine Hydrochloride RS.
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:
Triturate a portion of powdered Tablets,equivalent to about 50mg of triflupromazine hydrochloride,with 5mLof methanol,and centrifuge.A10-µLportion of the supernatant meets the requirements of Identificationtest Cunder Triflupromazine Hydrochloride.
B:
The solution prepared from the Tablets for measurement of absorbance in the Assayexhibits an absorbance maximum at 255±2nm.
Dissolution á711ñ—
Medium:
0.01Nhydrochloric acid;900mL.
Apparatus 1:
100rpm.
Time:
45minutes.
Procedure—
Determine the amount of C18H19F3N2S·HCl dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 305nm on filtered portions of the solution under test,suitably diluted with Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Triflupromazine Hydrochloride RSin the same Medium.
Tolerances—
Not less than 75%(Q)of the labeled amount of C18H19F3N2S·HCl is dissolved in 45minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 20mg of triflupromazine hydrochloride,to a separator,add 10mLof 0.1Nhydrochloric acid and 20mLof water,and mix.Add 6Nammonium hydroxide to render the mixture alkaline to litmus,add 1mLin excess,and extract with five 50-mLportions of chloroform,passing each extract through anhydrous sodium sulfate into a 250-mLvolumetric flask.Dilute with chloroform to volume,and mix.Evaporate 10.0mLof this solution under reduced pressure to dryness,and dissolve the residue in 0.1Nhydrochloric acid to make 100.0mL.Concomitantly determine the absorbances of this solution and of a Standard solution of USP Triflupromazine Hydrochloride RSin the same medium having a known concentration of about 8µg per mLin 1-cm cells at the wavelength of maximum absorbance at about 255nm,with a suitable spectrophotometer,using 0.1Nhydrochloric acid as the blank.Calculate the quantity,in mg,of C18H19F3N2S·HCl in the portion of Tablets taken by the formula:
2.5C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Triflupromazine Hydrochloride RSin the Standard solution,and AUand ASare the absorbances of the solution from the Tablets and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1979
Phone Number:1-301-816-8165
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