BRIEFING

 Glacial Acetic Acid. 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. Revise the Acceptance criteria in the Definition and Assay from NLT 99.5% and NMT 100.5% to NLT 98.0% and NMT 102.0%, which is typical for chromatographic procedures.

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

3. 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.

4. Replace the unit for concentration of potassium permanganate solution, which is 0.10 N, with 0.02 mol/L in Readily Oxidizable Substances for better clarity.

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.

 USP is seeking additional input and supporting data from stakeholders about specifications and methods related to organic impurities.

 (SM3: S. Banerjee)

 Case ID—SUB-536