Thiothixene Hydrochloride Injection
» Thiothixene Hydrochloride Injection is a sterile solution of Thiothixene Hydrochloride in Water for Injection. It contains an amount of thiothixene hydrochloride equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of thiothixene (C23H29N3O2S2).
Packaging and storage Preserve in single-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Endotoxin RS
Identification Transfer a volume of Injection, equivalent to about 20 mg of thiothixene hydrochloride, to a separator containing 20.0 mL of chloroform. Render the aqueous layer just basic with ammonium hydroxide, shake for 1 minute, and allow the layers to separate. Pass a portion of the chloroform layer through filter paper, previously washed with chloroform, and use the clear filtrate for the test. Proceed as directed in the Identification test under Thiothixene Capsules, beginning with Apply 10 µL of this test solution.
Bacterial endotoxins 85 It contains not more than 88.0 USP Endotoxin Units per mg of thiothixene.
pH 791: between 2.5 and 3.5.
Other requirements It meets the requirements under Injections 1.
Assay [notePerform the dilution operations in low-actinic glassware. ]
Mobile phase , Standard preparation, and Chromatographic systemPrepare as directed in the Assay under Thiothixene.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 2 mg of thiothixene, to a 100-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 Injection taken by the formula:
(100C / V)(rU / rS)in which C is the concentration, in mg per mL, of USP Thiothixene RS in the Standard preparation, V is the volume, in mL, of Injection taken, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 4853