BRIEFING

 Dronabinol. 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. In the Chemical Information section:

   • Update the molecular weight of dronabinol.

   • Add the UNII code for dronabinol.

2. Replace the use of Thin-Layer Chromatography in Identification B with the UV spectra agreement as obtained in the Assay.

3. Revise the Assay as follows:

   • Revise the Detector to support the proposed Identification B.

   • Update the Tailing factor requirement per Chromatography 〈621〉 and the use of the Standard solution for assessment instead of the System suitability solution.

   • Update the Relative standard deviation requirement per Chromatography 〈621〉.

   • Update the calculation formula in the Analysis to align with the current USP style.

4. Revise the test for Organic Impurities as follows:

   • Remove the Standard preparation cross reference to the Assay to allow for user flexibility.

   • Add a table and Note to the System suitability section to present relative retention times as an aid in peak assignment.

   • Remove the Tailing factor from the Suitability requirements as the remaining requirements are suitable to establish system suitability.

   • Update the Relative standard deviation requirement in the Suitability requirements per Chromatography 〈621〉 and supporting documentation.

   • Remove the Signal-to-noise ratio calculation as this is now included in Chromatography 〈621〉.

   • Revise the table in the Acceptance criteria to list only the relative response factors and limits for specified impurities, any unspecified impurity, and total impurities.

   • Add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility in the Acceptance criteria.

5. Update the molecular weight of USP Exo-tetrahydrocannabinol RS in the USP Reference Standards section to be consistent with current chemical information.

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

 (SM3: A. Leeks, Jr.)

 Case ID—SUB-2316