BRIEFING

 Fluphenazine Decanoate. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph as follows:

1. Replace the TLC test in Identification B with the retention time match in the proposed Assay.

2. Replace the current titration procedure in the Assay with a chromatographic procedure based on a method validated with the Kinetex EVO C18 brand of column with L1 packing. The typical retention time for fluphenazine decanoate is about 17 min.

3. Replace the Ordinary Impurities test with an Organic Impurities test based on a validated HPLC procedure. The liquid chromatographic procedure proposed is validated with the Kinetex EVO C18 brand of column with L1 packing. The typical retention time for fluphenazine decanoate is about 17 min.

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. Add a second table in the Acceptance criteria section to list relative response factors and the limits for specified impurities, any unspecified impurity, and total impurities. The Acceptance criteria in the Organic Impurities test is based on the impurity acceptance criteria in the European Pharmacopoeia 11.1 monograph. For more information about this format change, please see the USP Compendial Notice “Organic Impurities Procedures: Format Change for Presenting Relative Retention Times”.

5. Add a Labeling section and the Bacterial Endotoxins Test to support the intended use of the drug substance in preparing injectable or other sterile dosage forms.

6. Add USP Fluphenazine Decanoate N⁴-oxide RS and USP Fluphenazine Enanthate Dihydrochloride RS to the USP Reference Standards section to support the test for Organic Impurities.

 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—C117381