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Analysis of Betadex Sulfobutyl Ether Sodium According to USP-NF Method (SB-803 HQ)


Betadex sulfobutyl ether sodium is a solubilizer added to remdesivir and voriconazole for injection.
According to the United States Pharmacopeia and the National Formulary (USP 43-NF 38*), betadex sulfobutyl ether sodium assay should be carried out with a column filled with L37 packing material and meets following requirements. The use of a polymer-based aqueous SEC (GFC) column, OHpak SB-803 HQ, confirmed the requirements were met.

System suitability requirements:
   Relative standard deviation (RSD) of the peak area : ≤ 2.0%

*The version at the time of the application acquisition.

Sample : 20 μL
Betadex sulfobutyl ether sodium 10 mg/mL

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 : RI Column temp. : 35 ℃

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