Erythropoietin is a glycoprotein composed of 165 amino acids (molecular weight about 30,600 Da). It is a hormone promotes the production of red blood cells by targeting hematopoietic stem cells in bone marrow. Erythropoietin containing drugs are used for the treatment of renal anemia.
According to the European Pharmacopoeia (EP 9.6*), analysis of dimers and related substances with molecular masses greater than that of erythropoietin in "Erythropoietin concentrated solution" should be carried out with a column filled with hydrophilic silica gel, suitable for the separation of proteins with molecular weight 20,000 to 200,000 and meets following requirements. The PROTEIN LW-803 confirmed the requirements were met.

System suitability requirementsThe monomer peak area in the resolution solution must be 1.5 - 2.5 % of the monomer peak area in the reference solution**.
Resolution of the peaks of dimer and monomer in the resolution solution: ≥ 1.5

*The version at the time of the application acquisition. 
**Dilute 20 μL of the resolution solution 1.0 mL with the eluent.

Sample: 100 μL
(Resolution solution)  Erythropoietin for SEC system suitability CRS 0.2 mg/mL in eluent

1. 1.Dimer
2. 2.Monomer