BRIEFING

 Maltose. This proposal is based on the version of the monograph to be official on August 1, 2025. On the basis of comments and data received and to align with the Japanese Pharmacopoeia, the following changes are proposed:

1. Revise the Definition to provide a better description of maltose as a compound and to include an upper limit of maltose content of NMT 102.0%.

2. In the Assay, replace one 7.8-mm × 30-cm column with two in series 7.8-mm × 30-cm columns of the same packing and 9-µm particle size; change the Flow rate from 0.35 mL/min to 0.55 mL/min. The proposed changes improve the resolution among the peaks necessitating new Resolution requirements of NLT 2.0 between maltotriose and maltose and NLT 4 between maltose and glucose. This procedure was validated using the BioRad Aminex HPX-87N brand of column with L58 packing. The retention times of the maltotriose, maltose, and glucose peaks from the System suitability solution are about 15.5, 17.5, and 22.3 min, respectively. On the basis of the method performance, change the acceptance criterion for the Relative standard deviation from NMT 2.0% to NMT 1.0%. Update the equation to reflect that the Standard solution and Sample solution are prepared on the anhydrous basis. Add an upper limit of maltose content of NMT 102.0% to the Acceptance criteria, aligning it with that in the Definition and the upper limit in the Acceptance criteria in the Assayfor higher purity Maltose monohydrate.

3. Add a higher purity grade of Maltose monohydrate that meets the Acceptance criteria in the Assay of 98.0%–102.0% and is suitable for use in injectable dosage forms.

4. Add a monograph category titled Other Requirements that contains tests to confirm the quality of the higher purity Maltose monohydrate:

   • Related Substances that utilizes the HPLC procedure as in the Assay. The Acceptance criteria for this test align with those in the Japanese Pharmacopoeia.

   • pH 〈791〉. The Acceptance criteria for this test align with those in the Japanese Pharmacopoeia.

   • Chloride and Sulfate 〈221〉, Chloride. The Acceptance criteria for this test align with those in the Japanese Pharmacopoeia.

   • Chloride and Sulfate 〈221〉, Sulfate. The Acceptance criteria for this test align with those in the Japanese Pharmacopoeia.

   • Color of Solution. The Acceptance criteria for this test align with those in the Japanese Pharmacopoeia.

   • Clarity of Solution. The Acceptance criteria for this test align with those in the Japanese Pharmacopoeia.

   • Bacterial Endotoxins Test 〈85〉,

   • Microbial Enumeration Tests 〈61〉, and

   • Tests for Specified Microorganisms 〈62〉.

5. Add a Labeling section that requires to indicate whether Maltose is anhydrous or monohydrate and also whether it is intended for use in the manufacture of injectable dosage forms or must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins.

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

 (SE: G. Holloway)

 Case ID—SUB-1618