Analysis of Glycols and Sorbitol (SB-802 HQ)

Diethylene glycol (DEG) and ethylene glycol (EG) may become contaminates through improper manufacturing processes of raw materials or through contaminated solvents and excipients used in certain product productions. In April 2023, the U.S. Food and Drug Administration (FDA) issued a guidance for industries regarding testing for DEG and EG in pharmaceutical ingredients that have high potentials of DEG and EG contamination. OHpak SB-802 HQ, a column for aqueous SEC (GFC), used in this application is feasible separating DEG, EG, propylene glycol, and a sugar alcohol, sorbitol.

Sample: 50 µL
0.01 mg/mL each

  1. 1.Sorbitol
  2. 2.Diethylene glycol
  3. 3.Ethylene glycol
  4. 4.Propylene glycol
chromatogram of glycols
Column
Shodex OHpak SB-802 HQ (8.0 mm I.D. x 300 mm)
Eluent
H2O
Flow rate
0.5 mL/min
Detector
RI
Column temp.
30 ℃

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Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.

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