DEFINITION

Glucagon is a peptide hormone that has the property of increasing the concentration of glucose in the blood. It has the same structure (29 amino acids) as the hormone produced by the α-cells of the human pancreas. Glucagon is produced from either synthetic or microbial processes using recombinant DNA (rDNA) technology. When produced by microbial processes, the host cell-derived protein content and/or the host cell-derived or vector-derived DNA content are determined by validated methods. During the course of product development, it must be demonstrated that the manufacturing process produces Glucagon having a biological activity of NLT 0.80 USP Units/mg, using a validated bioassay approved by a competent authority. It contains NLT 93.0% and NMT 105.0% of glucagon (C₁₅₃H₂₂₅N₄₃O₄₉S) of synthetic origin, calculated on the anhydrous, acetic acid-, ammonium-, and chloride-free basis; and NLT 90% and NMT 105% of glucagon (C₁₅₃H₂₂₅N₄₃O₄₉S) of recombinant DNA origin, calculated on the anhydrous basis.