BRIEFING

 Indigotindisulfonate Sodium Injection. This proposal is based on the version of the monograph official as of May 1, 2018. It is proposed to revise the monograph with the following changes:

1. Revise the Definition from "NLT 90.0% and NMT 105.0%" to "NLT 90.0% and NMT 110.0%" based on approved product specification. The Acceptance criteria in the Assay are also updated accordingly.

2. Replace the nonspecific procedures in the Identification tests with a chromatographic retention time agreement and UV spectrum agreement using the proposed Assay.

3. Replace the nonspecific UV-based Assay with a validated liquid chromatographic procedure sharing the same Chromatographic system as in the proposed Organic Impurities test. Both procedures were validated using the Poroshell 120 SB-C8 brand of column with L7 packing. The typical retention time for indigotindisulfonate is about 43 min.

4. Replace the nonspecific reference to Injections and Implanted Drug Products 〈1〉 with specific references for Particulate Matter in Injections 〈788〉 and Sterility Tests 〈71〉 to align with the submission.

5. Replace the use of the numerical acceptance limit with “Meets the requirements” in the Bacterial Endotoxins Test 〈85〉 to align with the general chapter.

6. Revise the Packaging and Storage section for consistency with the FDA-approved package insert.

7. Add USP Indigotindisulfonate Sodium System Suitability Mixture RS to the USP Reference Standards section to support the proposed test for Organic Impurities.

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

 This proposal has undergone the prospective harmonization process with the European Pharmacopoeia.

 (SM4: Y. Yang)

 Case ID—SUB-1390