BRIEFING

 Atracurium Besylate Injection. 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. Add Identification B based on the UV spectrum agreement as obtained in the Assay.

2. Revise the Assay as follows:

   • Revise the Detector to support the proposed Identification B.

   • Add Tailing factor to the Suitability requirements.

   • Update the Relative standard deviation requirement from NMT 2.0% to NMT 1.0% to be consistent with the expectations for modern chromatographic systems and supporting data.

   • Add the calculation for calculating percentage of each isomer in the labeled amount of atracurium besylate.

3. Revise the test for Organic Impurities as follows:

   • Rename the Standard stock solution as System suitability solution and revise the Suitability requirements.

   • 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”.

   • Add the Sensitivity solution and revise the Suitability requirements to align with the reporting threshold.

   • Add a Relative standard deviation for the cis-cis isomer in the Suitability requirements.

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

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

   • Rename all the compounds in the new Table 2 based on the updated nomenclature.

4. Replace the use of the numerical acceptance limit with "Meets the requirements" in the Bacterial Endotoxins Test to align with the general chapter.

5. Delete the test for Injections and Implanted Drug Products and add the Particulate Matter in Injections and Container Content for Injections tests to the Specific Tests section.

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

 (SM4: D. Singh)

 Correspondence Number—C157589