BRIEFING

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

1. Revise the test for Organic Impurities as follows:

   • Add the Sensitivity solution to support the addition of the Signal-to-noise ratio requirement.

   • Delete the Tailing factor requirement as the other Suitability requirements are sufficient.

   • Add a table and a Note to the System suitability to present relative retention times as an aid in peak assignment. Revise the table in the Acceptance criteria to list only the limits for specified impurities, any unspecified impurity, and total impurities.

   • In the Acceptance criteria, add a reporting threshold based on User-Determined Reporting Thresholds 〈477〉.

2. Add the storage temperature in the Packaging and Storage section.

3. Update the chemical name of USP Indomethacin Related Compound A RS in the USP Reference Standards section.

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

 (SM2: M. Fadadu)

 Case ID—SUB-1022