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Hypromellose Ophthalmic Solution

BRIEFING

 Hypromellose Ophthalmic 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 the current Identification B to eliminate the use of a flame for safety concerns with a test based on the retention time agreement in the Assay.

  2. Replace the current Assay with a liquid chromatographic procedure validated using the PolySep-GFC-P 6000 brand of column with L39 packing. The typical retention time for hypromellose is about 9 min.

  3. Add storage requirements in the Packaging and Storage section based on approved package inserts.

  4. Add an Ophthalmic Products—Quality Tests, Particulate and Foreign Matter 〈771〉 test to the Specific Tests section.

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

 (SM3: A. Leeks, Jr.)

 Case ID—SUB 1397 and SUB-2794

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USP Hypromellose RS
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