BRIEFING

 Chlorpromazine Hydrochloride Oral Concentrate. This proposal is based on the version of the monograph official as of June 15, 2021. It is proposed to revise the monograph with the following changes:

1. Revise Identification A to be based on retention time agreement from the proposed Assay instead of from the TLC procedure.

2. Revise Identification B to be based on UV spectrum agreement from the proposed Assay instead of from the counterion identification.

3. Replace the UV-based Assay with a more specific LC procedure which shares the same Column and Mobile phase as those in the proposed Organic Impurities procedure. Both procedures were validated using the LiChrospher 60 RP-select B brand of column with L7 packing. The typical retention time for chlorpromazine in the Assay and Organic Impurities test is about 7 min.

4. Delete the test for the Limit of Chlorpromazine Sulfoxide based on TLC as the proposed test for Organic Impurities includes the analysis of chlorpromazine sulfoxide (chlorpromazine related compound A).

5. Propose Acceptance criteria for the Organic Impurities test based on submissions received. Manufacturers are encouraged to submit their FDA-approved specifications to USP if different.

6. Add a reference to Tests for Burkholderia Cepacia Complex 〈60〉 to align with the approved submission.

7. Separate the references to Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉 to more clearly communicate the requirements associated with each of the general chapters, and add acceptance criteria for Microbial Enumeration Tests 〈61〉.

8. Revise the Packaging and Storage section requirement for consistency with the FDA-approved package insert.

9. Add USP Chlorpromazine Related Compound A RS and USP Sodium Benzoate RS to the USP Reference Standards section to support the proposed test for Organic Impurities.

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

 (SM4: Y. Yang)

 Case ID—SUB-2076