Analysis of Polyethylene Glycol 3350 According to USP-NF Method (2) (SB-803 HQ)

According to the United States Pharmacopeia and the National Formulary (USP 42-NF 37*), "SPECIFIC TESTS: Apparent Weight-Average Molecular Weight and Polydispersity" for "Polyethylene Glycol 3350" should be carried out with a column filled with L37 packing material. When the USP polyethylene glycol 3350 reference standard (polydispersity unknown) was analyzed using the OHpak SB-803 HQ filled with L37 packing material, the apparent weight-average molecular weight was confirmed to be approximately 3360, which is within the acceptance criteria.

Acceptance criteriaApparent weight-average molecular weight (Sample solution):3015 - 3685 g/mol
Polydispersity  (Sample solution):90% - 110% of the value stated on the label or within the range indicated on the label

*The version at the time of the application acquisition.

Sample: 10 µL each
(Sample solution) 1.0 mg/mL of USP Polyethylene Glycol 3350 RS in eluent

  1. 1.Polyethylene glycol 3350

(Standard solutions) 1.0 mg/mL each of five polyethylene glycol standards in eluent

  1. 2.polyethylene glycol (Mp; 6,420)
  2. 3.polyethylene glycol (Mp; 4,120)
  3. 4.polyethylene glycol (Mp; 3,420)
  4. 5.polyethylene glycol (Mp; 2,010)
  5. 6.polyethylene glycol (Mp; 970)
Column
Shodex OHpak SB-803 HQ (8.0 mm I.D. x 300 mm)
Eluent
H2O
Flow rate
0.8 mL/min
Detector
RI (35 ℃)
Column temp.
35 ℃

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