BRIEFING

 〈209〉 Low Molecular Weight Heparin Molecular Weight Determinations. This proposal is based on the version of the chapter official as of April 1, 2023. The chapter currently includes two Notes that describe System suitability solution preparation and Suitability requirements to be applied only when no product monograph is available. These Notes specify the use of USP Dalteparin Sodium (Lyophilized) RS (5 mg/mL) as the System suitability solution and define acceptance criteria for its molecular weight. A compendial usage review determined that only two monographs, Dalteparin Sodium and Enoxaparin Sodium, reference this chapter. Both monographs provide complete instructions for system suitability solution preparation and acceptance criteria. Thus, the Notes in the chapter duplicate monograph-specific directions. On the basis of this information, the Biologics Monographs 1—Peptides, Oligonucleotides and Complex Carbohydrates Expert Committee proposes the following revisions to this chapter:

1. Delete the Note in the System suitability solution preparation in Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography.

2. Delete the Note in the Suitability requirements for Molecular Weight Measurements of Low Molecular Weight Heparins by Gel Permeation Chromatography.

3. Delete the USP Dalteparin Sodium (Lyophilized) RS from the USP Reference Standards 〈11〉 section.

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

 (BIO1: J. Sun)

 Case ID—SUB-3103