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Analysis of Lactose According to Chinese Pharmacopoeia 2025 Edition (VG-50 4E)

The Chinese Pharmacopoeia 2025 Edition*, Part IV, the monograph for Lactose, analysis by high‑performance liquid chromatography specifies the use of a column packed with amino silica or amino polymer gel. HILICpak VG-50 4E column confirmed the requirement was met.

System suitability requirementResolution between lactose and sucrose: > 1.5

*The version at the time of the application acquisition.

Sample: 10 µL
5 mg/mL each in H2O/CH3CN=50/50

  1. 1.Sucrose
  2. 2.Lactose
Chromatogram of Lactose
Column
Shodex HILICpak VG-50 4E (4.6 mm I.D. x 250 mm)
Eluent
H2O/CH3CN=30/70
Flow rate
1.0 mL/min
Detector
RI (30 ℃)
Column temp.
30 ℃

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