BRIEFING

 Aripiprazole. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to make the following changes:

1. Update the chemical information for Aripiprazole to include the monohydrate form.

2. Update the Definition and Acceptance criteria in the Assay to include the monohydrate form.

3. Revise Identification A to accomodate the monohydrate form. Add the Standard and Sample preparations for aripiprazole monohydrate.

4. Clarify the protect from light statements in the Assay and Organic Impurities test to specify that the requirement applies to solutions containing aripiprazole and/or aripiprazole related compound F.

5. Revise the Assay as follows:

   • Clarify the preparation of 0.05% trifluoroacetic acid and update solution references, as appropriate.

   • Remove the System suitability solution and Resolution requirement.

   • Update the System suitability section, including the requirements for Tailing factor and Relative standard deviation, to reflect the requirements of Chromatography 〈621〉 using the Standard solution.

6. Revise the test for Organic Impurities as follows:

   • Replace the cross-references to the Assay for the System suitability solution, Standard solution, and System suitability section with updated, direct text.

   • Add the System suitability solution and Resolution requirement from the Assay.

   • Add a Standard solution and Relative standard deviation requirement.

   • Add a Sensitivity solution and Signal-to-noise ratio requirement.

   • Revise the calculation to determine the percentage of any impurity using the concentrations of the Standard solution and Sample solution in addition to their peak responses.

   • Add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility.

   • Update the acceptance criterion in the table from "Any other individual impurity" to "Any unspecified impurity" to align with current expectations.

7. Specify that the Loss on Drying test is for the anhydrous form.

8. Add the Water Determination test if Aripiprazole is labeled as the monohydrate form.

9. Add a Labeling requirement for the monohydrate form.

10. Update the chemical information for USP Aripiprazole Related Compound F RS within the USP Reference Standards <11> section.

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

 (SM4: S. Dragan)

 Case ID—SUB-1179