The separation of EPO from other proteins in medical products formulated with different stabilizers.
The RP-HPLC method, useful for the separation of a protein of the erythropoietin formulations with different stabilizers, was elaborated. Using this method, rhEPO, HSA and other proteins, can be determined, depending on the sample composition. The method is sensitive and rapid. Our results indicate that this method is useful for quality control of rhEPO in final drug preparations with albumin as stabilizer. The method was also capable of distinguishing products from different manufacturers.
Wilczyńska
Jadwiga Dudkiewicz
JD
Department of Biochemistry and Biopharmaceuticals, National Institute of Public Health, 00-750 Warsaw, 30/34 Chełmska Str., Poland. jadwig@il.waw.pl
Roman
Iza
I
Anuszewska
Elzbieta
E
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D004921:Erythropoietin / Q000032:analysis*; D011506:Proteins / Q000032:analysis*; D011994:Recombinant Proteins
D011506:Proteins; D011994:Recombinant Proteins; D004921:Erythropoietin