BRIEFING

 Isopropyl Alcohol. The proposal is based on the version of the monograph effective as of December 1, 2022. Due to the requirements of the Assay and Volatile Impurities test, it is necessary to prepare the System suitability solution by adding 200 μL/L methanol and 1000 μL/L ethyl acetate to the existing USP 2-Propanol System Suitability RS (isopropyl alcohol with 0.1% each of ethyl ether, acetone, diisopropyl ether, 1-propanol, 2-butanol). On the basis of information received from USP Reference Standards Development, USP has prepared and qualified a new replacement lot of USP 2-Propanol System Suitability RS which contains isopropyl alcohol with approximately 0.1% each of ethyl ether, acetone, diisopropyl ether, 1-propanol, 2-butanol, and ethyl acetate, and 0.02% of methanol. Because the composition is changed in the new lot of USP 2-Propanol System Suitability RS, it is proposed to revise the System suitability solution in the Assay to eliminate the step of the addition of 200 μL/L of methanol and 1000 μL/L of ethyl acetate to USP 2-Propanol System Suitability RS.

 The number of replicate injections was incorporated into the Assay Suitability requirements.

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

 Please note that the new lot of USP 2-Propanol System Suitability RS, which contains methanol and ethyl acetate, is not suitable for the current monograph. Conversely, the current lot of USP 2-Propanol System Suitability RS, which lacks methanol and ethyl acetate, will no longer be suitable for use once the Isopropyl Alcohol Expedited Revision becomes effective on March 1, 2026. A customer communication letter will be posted on the USP store product page as the date approaches.

 This proposal is targeted for publication in FCC 15.

 (FI: J. Kong)

 Case ID—SUB-2311