BRIEFING

 Olanzapine Tablets. This proposal is based on the version of the monograph official as of July 1, 2023. It is proposed to revise the monograph with the following changes:

1. Add Identification B based on the retention time agreement as obtained in the Assay. Additionally, stakeholders are encouraged to submit a validated identification method, which does not require the use of chloroform, to replace Identification A.

2. Add Run time information for the chromatographic systems in the Assay and Dissolution Test 1 and Test 2.

3. Update the Relative standard deviation requirement for the Assay from NMT 2.0% to NMT 1.0% to be consistent with the expectation for modern chromatographic systems.

4. Revise the test for Organic Impurities as follows:

   • Update the Sample solution concentration to reference a single concentration per current practice.

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

   • In the Acceptance criteria, add a reference to User-Determined Reporting Thresholds 〈477〉 for user flexibility. For more information about this change, please see the USP Compendial Notice “New Chapter 〈477〉 User-Determined Reporting Thresholds and its implementation in USP–NF Monographs”.

   • Update Table 3 in the Acceptance criteria with the relative response factor of 2.1 for olanzapine lactam, and to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

5. Add the updated chemical names for USP Olanzapine Related Compound A RS and USP Olanzapine Related Compound B RS in the USP Reference Standards section.

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

 (SM4: R. Nguyen)

 Case ID—SUB-274