Thioridazine Hydrochloride Oral Solution
» Thioridazine Hydrochloride Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C21H26N2S2·HCl.
Packaging and storage Preserve in tight, light-resistant containers, at controlled room temperature.
Labeling Label it to indicate that it is to be diluted to appropriate strength with water or other suitable fluid prior to administration.
USP Reference standards 11
USP Thioridazine Hydrochloride RS.
noteThroughout 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 volume of Oral Solution containing 50 mg of thioridazine hydrochloride, diluted with water to 25 mL, meets the requirements under IdentificationOrganic Nitrogenous Bases 181, 2 mL of sodium bicarbonate solution (1 in 12) being used in place of the 2 mL of 1 N sodium hydroxide specified in the test.
Alcohol content 611: not more than 4.75% of C2H5OH.
Assay [noteConduct this procedure with a minimum of exposure to light.]
Ammoniacal chloroform Shake 125 mL of chloroform with 5 mL of ammonium hydroxide in a separator, slowly filter the bottom layer through filter paper containing anhydrous sodium sulfate, and discard the top layer.
Standard preparation Dissolve a suitable quantity of USP Thioridazine Hydrochloride RS, accurately weighed, in Ammoniacal chloroform to obtain a solution having a known concentration of about 6 µg per mL.
Assay preparation Pipet a portion of Oral Solution, equivalent to about 120 mg of thioridazine hydrochloride, into a separator containing 15 mL of water. Render alkaline with ammonium hydroxide, and extract with three 25-mL portions of Ammoniacal chloroform. Filter the extracts through a pledget of glass wool into a 200-mL volumetric flask. Rinse the filter, add chloroform to volume, and mix. Dilute 2.0 mL of this solution with Ammoniacal chloroform to 200.0 mL, and mix.
Procedure Concomitantly determine the absorbances of the Standard preparation and the Assay preparation in 1-cm cells at the wavelength of maximum absorbance at about 265 nm, with a suitable spectrophotometer, using Ammoniacal chloroform as the blank. Calculate the quantity, in mg, of C21H26N2S2·HCl in each mL of the Oral Solution taken by the formula:
20(C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Thioridazine Hydrochloride RS in the Standard preparation, V is the volume, in mL, of Oral Solution taken, and AU and AS are the absorbances of the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3729