The Chinese Pharmacopoeia 2025 Edition*, Part IV, the high‑performance liquid chromatography method for “Human Serum Albumin Multimers” specifies the use of a high‑performance size‑exclusion chromatography (SEC) column packed with hydrophilic silica gel, with an exclusion limit of 300 kDa, a particle size of 10 µm, and dimensions of 7.5 mm (I.D.) x 60 cm (L)**. PROTEIN KW-803 column confirmed the requirements were met.

System suitability requirements

Resolution between the human serum albumin monomer peak and dimer peak: > 1.5
Tailing factor of the human serum albumin monomer peak: 0.95 - 1.40

*The version at the time of the application acquisition.
**Chinese Pharmacopoeia 2025 edition allows changes in column dimensions, packing material, and particle sizes. 

Sample: 20 µL
Human serum albumin 12 mg/mL

1. 1.Dimer
2. 2.Monomer