According to the Japanese Pharmaceutical Excipients 2018 (Notification from the Ministry of Health, Labour and Welfare: March 7, 2022*), “Assay (1) D-Mannitol" for “D-Mannitol and Corn Starch Granules" should be carried out with a column filled with strong acidic ion-exchange resin consist of polystyrene carrying sulfonic acid groups (Ca type). The SUGAR EP SC1011-7F confirmed the requirements were met.

System suitability requirements

Theoretical plate number of D-mannitol (Satndard solution (2)): ≥ 6,000
Symmetry factor of D-mannitol (Satndard solution (2)): 0.8 - 1.5
Relative standard deviation of D-mannitol peak area (Satndard solution (2)): ≤ 1.0% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 20 µL
(Standard solution (2)) 5 mg/mL of D-Mannitol in H₂O

1. 1.D-Mannitol 5 mg/mL