BRIEFING

 Thiothixene Capsules. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes.

1. Remove the thin-layer chromatography test in the Identification section.

2. Add Identification A based on the retention time agreement of the major peak of the Sample solution and the Standard solution, as obtained in the proposed Assay.

3. Add Identification B based on the UV spectrum agreement of the major peak of the Sample solution and the Standard solution, as obtained in the proposed Assay.

4. Replace the LC procedure in the Assay and add a test for Organic Impurities based on an LC procedure that was validated using the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention time for thiothixene is about 4.7 min.

5. Add a reference to Ultraviolet-Visible Spectroscopy 〈857〉 in the Dissolution test.

6. Update the Packaging and Storage section to include storage conditions consistent with the product label.

7. In the USP Reference Standards section, add USP (E)-Thiothixene RS and USP Thiothixene Related Compound A RS to support the proposed test for Organic Impurities.

 Stakeholders are encouraged to submit their FDA-approved specifications, if different from the proposed ones, to USP for consideration. USP is interested in receiving a validated dissolution test with supporting data to replace the currently official Dissolution test which requires the use of chloroform.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (SM4: S. Singireddy)

 Case ID—SUB-729, SUB-1319