BRIEFING

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

1. Revise the Acceptance criteria in the Definition and the Assay from NLT 36.0% and NMT 37.0% to NLT 35.8% and NMT 37.2%, which is typical for chromatographic procedures.

2. Add Identification B which is based on the chromatographic retention time agreement 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. Update the storage condition in the Packaging and Storage section to be consistent with the current product information available.

6. 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-535