Betadex sulfobutyl ether sodium plays a crucial role as a solubilizer in the formulation of remdesivir and voriconazole for injection. To ensure compliance with USP 43-NF 38*, betadex sulfobutyl ether sodium assay must be carried out using the L37 packing material. The OHpak SB-803 HQ, a polymer-based aqueous SEC (GFC) column, was used to confirm these requirements and deliver accurate results.
System suitability requirements:
Relative standard deviation (RSD) of the peak area: ≤ 2.0%
*The version at the time of the application acquisition.
Column : Shodex OHpak SB-803 HQ (8.0 mm I.D. x 300 mm) Eluent : 0.1 M potassium nitrate in a mixture of acetonitrile and water (1:4) Flow rate : 1.0 mL/min Detector : Shodex RI Column temp. : 35 ℃
