Thiothixene Hydrochloride for Injection
» Thiothixene Hydrochloride for Injection is a sterile, dry mixture of Thiothixene Hydrochloride and Mannitol. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C23H29N3O2S2.
Packaging and storage— Preserve in light-resistant Containers for Sterile Solids as described under Injections 1.
Identification— Constitute a vial of Thiothixene Hydrochloride for Injection with 2.2 mL of water. Further dilute one volume of the constituted solution with 4 volumes of methanol to obtain a test solution containing 1 mg of thiothixene per mL. Apply 10 µL of this test solution and 10 µL of a Standard solution containing 1 mg of USP Thiothixene RS per mL in the same medium to a suitable 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 isopropyl alcohol and diethylamine (25:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, air-dry for 30 minutes, and then oven-dry at 110 for 30 minutes. Locate the spots on the plate by viewing under short-wavelength UV light. Spray the plate with alkaline permanganate spray reagent (prepared by dissolving 0.5 g of potassium permanganate and 2.0 g of sodium carbonate in 100 mL of water): the RF value of the principal spot obtained from the test solution, under both detection conditions, corresponds to that obtained from the Standard solution.
Bacterial endotoxins 85 It contains not more than 88.0 USP Endotoxin Units per mg of thiothixene.
pH 791: between 2.3 and 3.7, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 4.0%.
Other requirements— It meets the requirements under Injections 1.
Assay— [note—Perform the dilution operations in low-actinic glassware.]
Mobile phase , Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Thiothixene.
Assay preparation— Constitute a vial of Thiothixene Hydrochloride for Injection with an accurately measured volume (VL mL) of water as directed in the labeling. Transfer an accurately measured volume (VF mL) of the constituted solution, equivalent to about 5 mg of thiothixene, to a 250-mL volumetric flask, dilute with methanol to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Thiothixene. Calculate the quantity, in mg, of C23H29N3O2S2 in each mL of the constituted solution taken by the formula:
(250CVL / VF)(rU / rS)
in which C is the concentration, in mg per mL, of USP Thiothixene RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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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
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USP32–NF27 Page 3734
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.