DEFINITION

Epoetin is the recombinant form of human erythropoietin. It is a 165-amino acid glycoprotein manufactured using recombinant DNA technology. The presence of the impurities, host cell DNA, and host cell protein in Epoetin is process-specific, and is controlled through the purification process. The impurity levels are determined by validated methods and limits approved by the competent regulatory authority. It has a potency of NLT 140,000 and NMT 200,000 international units (IU) per absorbance unit (AU) at 280 nm.