BRIEFING

 Norepinephrine Bitartrate 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. Update the Definition to be consistent with current USP style.

2. Replace the colorimetric test in Identification A with a chromatographic retention time agreement as obtained in the proposed Assay.

3. Replace the colorimetric test in Identification B with a UV spectrum agreement as obtained in the proposed Assay.

4. Replace the HPLC based Assay with an LC procedure similar to the proposed Organic Impurities test. The liquid chromatographic procedure is validated using the Chromolith Performance RP-18e brand of column with L1 packing. The typical retention time for norepinephrine is about 4 min.

5. Add an Organic Impurities test based on a validated liquid chromatographic procedure. The liquid chromatographic procedure is validated using the Chromolith Performance RP-18e brand of column with L1 packing. The typical retention time for norepinephrine is about 4.3 min. Manufactures are encouraged to submit FDA-approved specifications.

6. Revise the requirement in the Bacterial Endotoxins Test to remove the numerical limit and refer to Bacterial Endotoxins Test 〈85〉 for the calculation of limits.

7. Add a storage condition to the Packaging and Storage section.

8. Add USP Norepinephrine Related Compound D RS and USP Norepinephrine Related Compound E RS to the USP Reference Standards section to support the proposed procedures.

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

 (SM2: F. Gu)

 Correspondence Number—C225752