According to the United States Pharmacopeia and the National Formulary (USPNF 2025 Issue 1*), "SPECIFIC TESTS: Molecular Weight Limit" for "Polydextrose" should be carried out with a column filled with L39 packing material. The OHpak SB-804 HQ, a column filled with L39 packing material, confirmed the requirements were met.

System suitability requirementsResolution (Standard solution): Dextrose and stachyose are baseline separated from each other and also baseline separate from pullulan standard with a molecular weight of 5,800.
Correlation coefficient (R) of the calibration curve (Standard solution): ≥0.9999.

*The version at the time of the application acquisition.

Sample: 50 µL
(Standard solution) USP Dextrose RS, stachyose, and pullulan standards 2 mg/mL each in eluent

1. 1.Pullulan (*Mp 107,000)
2. 2.Pullulan (*Mp 21,100)
3. 3.Pullulan (*Mp 5,900)
4. 4.Stachyose
5. 5.Dextrose

*Mp: Peak top molecular weight

Sample: 50 µL

(Sample solution) USP Polydextrose RS 5 mg/mL in eluent

1. 6.Polydextrose