Thiothixene Hydrochloride Injection, chemical structure, molecular formula, Reference Standards
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.
USP Reference standards á11ñ
USP Endotoxin RS.USP Thiothixene RS.
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.
between 2.5and 3.5.
It meets the requirements under Injections á1ñ.
[NOTEPerform the dilution operations in low-actinic glassware.]
,Standard preparation,and Chromatographic systemPrepare as directed in the Assayunder Thiothixene.
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.
Proceed as directed for Procedurein the Assayunder Thiothixene.Calculate the quantity,in mg,of C23H29N3O2S2in each mLof the Injection taken by the formula:
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.
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
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