Analysis of Ethylene Glycol and Diethylene Glycol in reference to USP-NF “Polyethylene Glycol 3350” (SB-802 HQ)

According to the United States Pharmacopeia and the National Formulary (USP-NF 2021 Issue 1*), under “Limit of Ethylene Glycol and Diethylene Glycol” in “Polyethylene Glycol 3350”, analysis should be carried out with a column with L89 packing material and requires a resolution of Ethylene Glycol (EG) and Diethylene Glycol (DEG) to be ≥ 0.9. OHpak SB-802 HQ, a column for aqueous SEC (GFC), was used in this application with the conditions mentioned in the “Limit of Ethylene Glycol and Diethylene Glycol” analysis.

*The version at the time of the application acquisition.

Sample: 50 µL
0.01 mg/mL each (in 50 µg/L NaN3 aq.)

  1. 1.Diethylene glycol
  2. 2.Ethylene glycol
chromatogram of DEG and EG
Column
Shodex OHpak SB-802 HQ (8.0 mm I.D. x 300 mm)
Eluent
50 mg/L NaN3 aq.
Flow rate
0.5 mL/min
Detector
RI (35 ℃)
Column temp.
35 ℃

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