BRIEFING

 Fluphenazine Decanoate Injection. This proposal is based on the version of the monograph to be official on May 1, 2024. It is proposed to revise the monograph as follows:

1. Replace Identification A based on the wet chemistry, with the UV spectral agreement as in the proposed Assay.

2. Replace both the current HPLC Assay and the Limit of Fluphenazine and Late-Eluting Impurities test with a new HPLC Assay and Organic Impurities test based on an HPLC procedure validated with the Kinetex EVO C18 brand of column with L1 packing. The typical retention time for fluphenazine decanoate is about 17 min.

3. Propose the Acceptance criteria in the Organic Impurities test based on the impurity acceptance criteria in the British Pharmacopoeia 2022 monograph. Add a reporting threshold statement reflective of the Sensitivity solution and as per the International Council for Harmonisation Guideline Q3B(R2).

4. Add a table and Note in the System suitability section in the Organic Impurities test to present relative retention times as an aid in peak assignment. Revise and add a second table in the Acceptance criteria section to list relative response factors and the limits for specified degradation products, any unspecified degradation product, and total degradation products.

5. Add a Bacterial Endotoxins Test and Sterility Tests under Specific Tests to strengthen the monograph quality.

6. Add USP Fluphenazine Decanoate N⁴-oxide RS and USP Fluphenazine Enanthate Dihydrochloride RS and remove USP Fluphenazine Hydrochloride RS under the USP Reference Standards section to reflect the changes in the Assay and Organic Impurities test.

 Manufacturers are encouraged to submit their FDA-approved specifications to USP if they are different from those proposed in this revision.

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

 (SM4: I. Salahudeen)

 Correspondence Number—C166330