BRIEFING

 Maltodextrin. This proposal is based on the version of the monograph official as of May 1, 2023. On the basis of comments and data received, it is proposed to make the following changes:

1. Update the Definition to align with the updated acceptance criteria for Reducing Sugars (Dextrose Equivalent).

2. Add Identification A based on the newly proposed assay method.

3. Update the Dextrose Equivalent test to "Reducing Sugars (Dextrose Equivalent)" from a nonspecific titrimetric method to an HPLC method. The newly proposed HPLC method provides more specificity than the titrimetric method and is based on analyses performed with the Waters XBridge Amide brand of column with L68 packing with a Waters Acquity column in-line filter. The HPLC-based Assay provides a distinction between the various dextrose equivalent grades of Maltodextrin and variations within each product grade. The typical retention times for dextrose, maltose, maltotriose, maltotetraose, and other oligosaccharides [degree of polymerization (DP_5–8)] are 5.0, 5.5, 5.9, 6.4, 7.0, 7.6, 8.2, and 9.0 min, respectively.

4. Add acceptance criteria for Microbial Enumeration Tests 〈61〉 under the Specific Tests section.

5. Add USP Maltodextrin DE 10 RS to the USP Reference Standards section.

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

 (SE: S. Saladi)

 Case ID—SUB-577