Shodex proudly presents a validated application for the analysis of Hydrogenated Polydextrose in accordance with the latest USP-NF 2025 Issue 1 guidelines. According to the pharmacopeia, the “Molecular Weight Limit” test requires the use of a column filled with L39 packing material. The OHpak SB-804 HQ column, designed with this packing, has proven to meet all regulatory requirements.
The method demonstrates excellent system suitability:
- Baseline separation of dextrose, stachyose, and pullulan standards.
- Outstanding calibration performance with correlation coefficient (R) ≥ 0.9999.
By employing the OHpak SB-804 HQ under optimized conditions (aqueous sodium nitrate eluent, 0.8 mL/min flow, 45 ℃ column temperature), laboratories can achieve highly accurate molecular weight determination for hydrogenated polydextrose, ensuring compliance with USP-NF standards.
This successful application once again highlights the versatility of Shodex columns in pharmaceutical quality control and molecular weight analysis.
