Analysis of Polyethylene Glycol 3350 for Oral Solution According to USP-NF Method (SB-802.5 HQ)

According to the United States Pharmacopeia and the National Formulary (USP 40-NF 35*), "Assay for polyethylene glycol 3350" for "Polyethylene Glycol 3350 and Electrolytes for Oral Solution" should be carried out with an analytical column and its guard column filled with L25 packing material. OHpak SB-802.5 HQ and OHpak SB-G 6B (guard column) filled with L25 packing material confirmed the requirement was met.

System suitability requirementRelative standard deviation (RSD) (Standard preparation): ≤ 1.5%

*The version at the time of the application acquisition.

Sample: 20 µL
(Standard preparation) 0.72 mg/mL of polyethylene glycol 3350 (prepared according to USP-NF method)

Column
：Shodex OHpak SB-G 6B (6.0 mm I.D. x 50 mm) + SB-802.5 HQ (8.0 mm I.D. x 300 mm)
Eluent
：14 mg/L NaCl, 7.2 mg/L KCl, 16 mg/L NaHCO3, 54.8 mg/L Na2SO4 and 35.2 mg/L NH4Br in H2O (dilute 40.0 mL of Salt solution** with H2O to 1000 mL)
**0.35 mg/mL NaCl, 0.18 mg/mL KCl, 0.4 mg/mL NaHCO3, 1.37 mg/mL Na2SO4 and 0.88 mg/mL NH4Br in H2O
Flow rate
：1.0 mL/min
Detector
：RI (34 ℃)
Column temp.
：Ambient

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