BRIEFING

 Anastrozole 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 Identification A involving extraction of the analyte in diethyl ether with the UV spectral agreement of the major peak of the Sample solution to that of the Standard solution, as obtained in the Assay.

2. In the Assay:

   • Revise the Detector to support the proposed Identification A.

   • Add the Run time.

3. In the test for Organic Impurities:

   • Update the reagent name from ethyl 4-hydroxybenzoate to ethylparaben based on the available reagent names.

   • Add a Sensitivity solution for the assessment of Signal-to-noise ratio, in the Suitability requirements to align with the reporting thresholds.

   • Remove the Analysis time from the Chromatographic system.

   • In the Acceptance criteria, replace the "disregard limit" with 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".

   • Add Table 2 and a Note in the System suitability section to present relative retention times as an aid in peak assignment. Revise and change the table number in the Acceptance criteria section to list only the limits for the specified impurities, any unspecified degradation product, and total degradation products.

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

 (SM3: M. Jonnada)

 Case ID—SUB-559, SUB-835