Mesoridazine Besylate
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10H-Phenothiazine,10-[2-(1-methyl-2-piperidinyl)ethyl]-2-(methylsulfinyl)-,(±)-,monobenzenesulfonate.
(±)-10-[2-(1-Methyl-2-piperidyl)ethyl]-2-(methylsulfinyl)phenothiazine monobenzenesulfonate [32672-69-8].
»Mesoridazine Besylate contains not less than 98.0percent and not more than 102.0percent of C21H26N2OS2·C6H6O3S,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
USP Reference standards á11ñ—
USP Mesoridazine Besylate 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:
Infrared Absorption á197Mñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
methanol.
Absorptivities at 263nm,calculated on the dried basis,do not differ by more than 3.0%.
pHá791ñ:
between 4.2and 5.7,in a freshly prepared solution (1in 100).
Loss on drying á731ñ—
Dry it at 105
for 4hours:it loses not more than 0.5%of its weight.
for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Heavy metals,Method IIá231ñ:
0.002%.
Selenium á291ñ—
The absorbance of the solution from the Test Solution,prepared with 100mg of Mesoridazine Besylate and 100mg of magnesium oxide,is not greater than one-half that from the Standard Solution(0.003%).
Ordinary impurities á466ñ—
Test solution:
a solution in methanol having a known concentration of 14.1mg per mLequivalent to 10mg of mesoridazine per mL.
Standard solution:
methanol.
Eluant:
a mixture of chloroform,isopropyl alcohol,and ammonium hydroxide (87:12:1).
Visualization:
3
Application volume:
10µL.
Limit:
3.0%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 150mg of Mesoridazine Besylate,accurately weighed,in 70mLof 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 27.24mg of C21H26N2OS2·C6H6O3S.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1224
Pharmacopeial Forum:Volume No.30(4)Page 1262
Phone Number:1-301-816-8330