BRIEFING

 Tramadol Hydrochloride Tablets. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to revise the monograph with the following changes:

1. Replace the infrared spectroscopy test in Identification A with a UV spectrum agreement as obtained in the Assay to eliminate the usage of dichloromethane.

2. In the Assay:

   • Revise the Detector to include wavelength range to support the proposed addition of Identification A.

   • Add the particle size for the Column based on supporting data.

   • Tighten the requirement for the Relative standard deviation from NMT 2.0% to NMT 1.0% based on supporting data.

   • Add a Tailing factor requirement based on supporting data.

3. Delete the Procedure for content uniformity from the Uniformity of Dosage Units test to allow for flexibility.

4. In the Organic Impurities test:

   • Add the particle size for the Column based on the supporting data.

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

   • Update trivial names and chemical names in Table 1 and Table 2 to be consistent with current USP style.

   • Replace System sensitivity solution with Sensitivity solution.

   • Update the system suitability requirements by adding a Signal-to-noise ratio requirement and deleting the redundant Relative standard deviation requirement.

   • Delete the Note about disregarding any peaks due to solvent or excipients.

   • Revise Table 2 in the Acceptance criteria to list only the limits for specified impurities, any unspecified impurities, and total impurities.

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

5. Update the chemical information for USP Tramadol Related Compound A RS in the USP Reference Standards section.

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

 (SM2: F. Gu)

 Case ID—SUB-1756