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

Epoetin is an erythropoietin preparation used to treat anemia. According to the United States Pharmacopeia and the National Formulary (USP 41-NF 36*), "IMPURITIES: Limit of High Molecular Weight Proteins" for "Epoetin" should be carried out with a column filled with L20 packing material. The PROTEIN LW-803, a column filled with L20 packing material, confirmed the requirements were met.

 

System suitability requirementsMonomer retention time (System suitability solution): 8 - 10 min
Relative retention times (System suitability solution): 0.9 (dimer) and 1.0 (monomer) 
Relative standard deviation (RSD) of monomer peak area (System suitability solution): < 2.0%


*The version at the time of the application acquisition.

Sample: 40 µL
(System suitability solution) Erythropoietin 2 mg/mL in eluent
**Heated at 80 ℃ for 30 min

  1. 1.Dimer
  2. 2.Monomer
Chromatogram of indigestible dextrin
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 ℃

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