BRIEFING

 Dalteparin Sodium. This proposal is based on the version of the monograph official as of December 1, 2023. Due to the introduction of a new Reference Standard, USP Dalteparin Sodium (Lyophilized) RS, which will replace the current USP Dalteparin Sodium RS, it is proposed to revise the monograph with the following changes.

1. Update the preparation instructions for the Standard solution in Identification A to: "Dissolve 5 mg of USP Dalteparin Sodium (Lyophilized) RS in 0.7 mL of deuterium oxide with deuterated sodium 3-trimethylsilylpropionate."

2. Update the preparation instructions for the Sample solution in Identification A to: "Dissolve 5 mg of Dalteparin Sodium in 0.7 mL of deuterium oxide (99.9%) with deuterated sodium 3-trimethylsilylpropionate."

3. Revise the name of the USP Reference Standard from USP Dalteparin Sodium RS to USP Dalteparin Sodium (Lyophilized) RS in Identification A, Identification B, and in the USP Reference Standards section.

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

 The comment period for this revision ends on July 31, 2026. In the absence of any significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of January 1, 2027.

 (BIO1: J. Sun)

 Case ID—SUB-47