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 90.0percent and not more than 110.0percent of the labeled amount of thiothixene (C23H29N3O2S2).
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,protected from light.
Identification— Transfer a volume of Injection,equivalent to about 20mg of thiothixene hydrochloride,to a separator containing 20.0mLof chloroform.Render the aqueous layer just basic with ammonium hydroxide,shake for 1minute,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 Identificationtest under Thiothixene Capsules,beginning with “Apply 10µLof this test solution.”
Bacterial endotoxins á85ñ— It contains not more than 88.0USP Endotoxin Units per mg of thiothixene.
pHá791ñ: between 2.5and 3.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— [NOTE—Perform the dilution operations in low-actinic glassware.]
Mobile phase ,Standard preparation,and Chromatographic system—Prepare as directed in the Assayunder Thiothixene.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 2mg of thiothixene,to a 100-mLvolumetric flask,dilute with methanol to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Thiothixene.Calculate the quantity,in mg,of C23H29N3O2S2in each mLof the Injection taken by the formula:
(100C/V)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Thiothixene RSin the Standard preparation,Vis the volume,in mL,of Injection taken,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1921
Phone Number:1-301-816-8330