Thioridazine Oral Suspension
» Thioridazine Oral Suspension contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of thioridazine (C21H26N2S2).
Packaging and storage— Preserve in tight, light-resistant containers. Store at a temperature not exceeding 30.
USP Reference standards 11
USP Thioridazine RS
note—Throughout 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.
Identification— [note—Conduct this test without exposure to daylight, and with a minimum of exposure to artificial light.] Transfer 40 mL of the combined chloroform extracts obtained for the Assay to a 50-mL beaker, and reduce the volume to 1 mL by evaporating the chloroform with the aid of a stream of nitrogen. Apply 25 µL of this test solution and 25 µL of a Standard solution of USP Thioridazine RS in chloroform containing 4 mg per mL to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of toluene, acetone, solvent hexane, and diethylamine (15:15:15:1) until the solvent front has moved about 10 cm from the origin. Remove the plate from the developing chamber, mark the solvent front, and locate the spots on the plate by viewing under short-wavelength and long-wavelength UV light: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution.
Uniformity of dosage units 905
for oral suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral suspension packaged in multiple-unit containers: meets the requirements.
Specific gravity 841: between 1.180 and 1.310.
pH 791: between 8.0 and 10.0.
Assay— Transfer an accurately measured volume of Oral Suspension, freshly mixed but free from air bubbles, equivalent to about 100 mg of thioridazine, to a 125-mL separator, using a pipet calibrated to contain the required volume. Rinse the pipet with 10 to 15 mL of water, adding the rinsing to the separator. Render the mixture alkaline by adding several drops of ammonium hydroxide, and mix. Extract with six 30-mL portions of chloroform, and filter the extracts through anhydrous sodium sulfate, collecting the combined filtrates in a 200-mL volumetric flask. Dilute quantitatively and stepwise with chloroform to obtain a solution having a concentration of about 100 µg of thioridazine per mL. [note—Reserve a 40-mL portion of this solution for the Identification test.] Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with chloroform to volume, and mix. Concomitantly determine the absorbances of this Assay solution and a Standard solution of USP Thioridazine RS in chloroform having a known concentration of about 5 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 266 nm, with a suitable spectrophotometer, using chloroform as the blank. Calculate the quantity, in mg, of thioridazine (C21H26N2S2) in each mL of the Oral Suspension taken by the formula:
20(C/V)(AU / AS)
in which C is the concentration, in µg per mL, of USP Thioridazine RS in the Standard solution; V is the volume, in mL, of Oral Suspension taken; and AU and AS are the absorbances of the Assay solution and the Standard solution, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3728
Pharmacopeial Forum: Volume No. 29(6) Page 1992