Assay 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*), analysis for the assay of polyethylene glycol 3350 in "Polyethylene Glycol 3350 and Electrolytes for Oral Solution" should be carried out with a column filled with L25 packing material and meets following requirement. The OHpak SB-802.5 HQ confirmed the requirement was met.

System suitability requirement:
 Relative standard deviation (RSD): ≤ 1.5%

*The version at the time of the application acquisition.


Sample : 20 μL
1. Polyethylene glycol 3350
0.72 mg/mL


Columns      : 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)
Flow rate    : 1.0 mL/min
Detector     : RI
Column temp. : Ambient 

**Salt solution ; 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

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