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Acetic Acid Otic Solution

BRIEFING

 Acetic Acid Otic Solution. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:

  1. Replace Identification A based on the wet chemistry, with the chromatographic retention time agreement using the proposed Assay.

  2. Replace Identification B based on the wet chemistry, with the UV spectral 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. 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-602

USP REFERENCE STANDARDS FOR PURCHASE

USP Glacial Acetic Acid RS
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