Packaging and storage—
Preserve in single-dose containers, preferably of Type I glass, protected from light.
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.”
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—
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 C
23H
29N
3O
2S
2 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.
