BRIEFING

 Bendamustine Hydrochloride for Injection. 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. In the Assay, delete the Analysis time from the Chromatographic system.

2. In the test for Organic Impurities:

   • Add Solution A and Solution B to the list of solutions prepared as directed in the Assay for clarity.

   • Add a Note and table in the System suitability section to present relative retention times as an aid in peak assignment.

   • In the sections of Analysis and Acceptance criteria, change "impurity/impurities" to "degradation product(s)" to align with International Council for Harmonisation guidelines.

   • In the table of the Acceptance criteria section:

     • List only the relative response factors and limits for the specified degradation products, any unspecified degradation product, and total degradation products.

     • Specify that the limits are for the free base forms of bendamustine related compound A, bendamustine related compound B, and bendamustine related compound D.

3. Revise the chemical information for USP Bendamustine Related Compound A RS, USP Bendamustine Related Compound D RS, and USP Bendamustine Related Compound G RS in the USP Reference Standards section to reflect the hydrochloride forms of these USP Reference Standards.

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

 (SM3: J. Li)

 Correspondence Number—C324120