BRIEFING

 Methscopolamine Bromide Tablets. This proposal is based on the version of the monograph official as of March 1, 2019. On the basis of comments received, a revision to the test for Organic Impurities is necessary to add an acceptance criteria and a relative response factor for a degradation product. The following revisions to the monograph are also proposed:

1. In the Assay:

   • Remove the instruction to return to original conditions and re-equilibrate the system in Mobile phase.

   • Update the gradient table to reflect the equilibration back to original conditions based on validated methods of analysis.

2. The following additional updates to the test for Organic Impurities are proposed:

   • Add the Sensitivity solution to support the addition of a Signal-to-noise ratio requirement.

   • Add Table 2 and a Note in the System suitability section to present relative retention times as an aid in peak assignment.

   • Add a reference to the Standard solution and the Sensitivity solution in the System suitability section and Relative standard deviation and Signal-to-noise ratio requirements in the Suitability requirements section based on the validated method of analysis.

   • Revise Table 3 in the Acceptance criteria to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

   • Under the Acceptance criteria, add a reference to general chapter User-Determined Reporting Thresholds 〈477〉 for user flexibility.

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

 (SM3: R. Fales)

 Case ID—SUB-1560