BRIEFING

 Acetic Acid Irrigation. This proposal is based on the version of the monograph official as of May 1, 2018. It is proposed to revise the monograph with the following changes:

1. Add Identification B which is based on the chromatographic retention time agreement using the proposed Assay.

2. Replace the titration-based Assay with a validated liquid chromatographic procedure. The proposed HPLC procedure was validated using the InertSustain AQ-C18 brand of column with L1 packing. The typical retention time for acetic acid is about 5 min.

3. Replace the use of the numerical acceptance limit with "Meets the requirements" in the Bacterial Endotoxins Test to align with the general chapter.

4. Add a Labeling section to include the total osmolar concentration and contraindications according to the supporting data available.

5. Add the USP Reference Standards section to support the proposed Assay procedure.

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

 (SM3: S. Banerjee)

 Case ID—SUB-232