Analysis of Epoetin According to USP-NF Method (LW-803)

According to the United States Pharmacopeia and the National Formulary (USP 41-NF 36*), analysis of high molecular proteins in "Epoetin" (erythropoietin preparation) should be carried out with a column filled with L20 packing material and meets following requirements. The PROTEIN LW-803 confirmed the requirements were met.

System suitability requirements for monomer:
   Retention time: 8 to 10 min
　Relative standard deviation (RSD): ≤ 2.0%

*The version at the time of the application acquisition. 


Sample : 40 µL
Erythropoietin 2 mg/mL
(in Eluent)
Heat at 80 °C for 30 min
1. Dimer
2. Monomer

Column       : Shodex PROTEIN LW-803 (8.0 mm I.D. x 300 mm)
Eluent       : 20 mM Sodium citrate + 100 mM NaCl aq. (pH6.9 adjust with Hydrochloric acid)
Flow rate    : 1.0 mL/min
Detector     : UV (230 nm)
Column temp. : 25 °C