BRIEFING

 Bendamustine Hydrochloride. 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. Add the UNII codes of bendamustine hydrochloride, bendamustine hydrochloride monohydrate, and bendamustine free base in the chemical information section.

2. In the Assay, delete the Analysis time from the Chromatographic system.

3. 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.

   • Revise the table in the Acceptance criteria section as below:

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

     • Change "Any individual unspecified impurity" to "Any unspecified impurity" to align with International Council for Harmonisation guidelines.

     • List only the limits for the specified impurities, any unspecified impurity, and total impurities.

4. In the Specific Tests section:

   • Specify the Acceptance criteria of the Bacterial Endotoxins Test for clarification.

   • Delete the reference to the Tests for Specified Microorganisms as no related acceptance criteria in this general chapter is applicable to the article.

5. In the Additional Requirements section:

   • Revise the storage condition to "controlled room temperature" in the Packaging and Storage section.

   • Add the Labeling requirements.

   • 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—C324119