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
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