C21H26N2S2·HCl
407.04
10H-Phenothiazine,10-[2-(1-methyl-2-piperidinyl)ethyl]-2-(methylthio)-,monohydrochloride.
10-[2-(1-Methyl-2-piperidyl)ethyl]-2-(methylthio)phenothiazine monohydrochloride
[130-61-0].
Packaging and storage
Preserve in tight,light-resistant containers.
Identification
A:
Infrared Absorption á197Kñ.
B:
Asolution (1in 10)responds to the tests for Chloride á191ñ.
Melting range á741ñ:
between 159

and 165

,but the range between beginning and end of melting does not exceed 3

.
pHá791ñ:
between 4.2and 5.2,in a solution (1in 100).
Selenium á291ñ:
0.003%,a 100-mg specimen being used,100mg of magnesium oxide being added to the
Test Solution.
Chromatographic purity
[NOTEConduct this procedure in subdued lighting without delay.
]
Diluting solution:
a mixture of methanol and ammonium hydroxide (49:1).
Test solution
Transfer 100mg of Thioridazine Hydrochloride,accurately weighed,to a 5-mLvolumetric flask.Dissolve in and dilute with Diluting solutionto volume,and mix.
Standard solutions
Dissolve an accurately weighed quantity of
USP Thioridazine Hydrochloride RSin
Diluting solution,and dilute quantitatively,and stepwise if necessary,with
Diluting solutionto obtain a solution having a known concentration of 20.0mg per mL(
Standard solution A).Dilute appropriate portions of this solution quantitatively with
Diluting solutionto obtain five
Standard solutions Bto
Fhaving known concentrations of 0.1,0.067,0.025,0.02and 0.01mg per mL,respectively.The final concentrations of
Standard solutions Bto
Frepresent 0.5%,0.33%,0.125%,0.1%and 0.05%concentration of
Standard solution A,respectively.
Application volume:
5µL.
Developing solvent system:
a mixture of chloroform,isopropyl alcohol,and ammonium hydroxide (74:25:1).
Procedure
Apply equal spots of the
Test solutionand
Standard solutions Ato
Fas directed under
Ordinary Impurities á466ñ.Examine the plate under short-and long-wavelength UVlight,then spray the plate with Dragendorff's TS,dry the plate with a stream of nitrogen,and then spray with hydrogen peroxide TS:any secondary spot in the
Test solutionis not more than 0.5%,and the sum of all secondary spots is not more than 0.5%.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Assay
Dissolve about 350mg of Thioridazine Hydrochloride,accurately weighed,in 80mLof a solution of equal parts of glacial acetic acid and acetic anhydride,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 40.70mg of C21H26N2S2·HCl.