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*), “Dimers and related substances with molecular masses greater than that of erythropoietin” for “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. The PROTEIN LW-803 confirmed the requirements were met.

System suitability requirementsMonomer peak area in Reference solution**: ≥ 1.5 - 2.5% of the monomer peak area in Resolution solution
Resolution between the peaks of erythropoietin dimer and erythropoietin monomer (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) 0.2 mg/mL of Erythropoietin for SEC system suitability CRS  in eluent

1. 1.Dimer
2. 2.Monomer