〈123〉 Glucagon Bioidentity Tests

Glucagon is a peptide hormone that increases blood glucose levels via release of liver glycogen stores. A robust and precise physicochemical chromatographic procedure is used in the glucagon assay to assign potency on a mass basis. Bioidentity is still required in Glucagon for Injection, and two procedure options are presented here: an in vivo procedure based on release of glucose from freshly prepared rat liver cells (hepatocytes) stimulated with glucagon ex vivo or production of cyclic adenosine monophosphate (cAMP) in vitro in response to glucagon stimulation of the glucagon receptor cell line. To meet the acceptance criteria of the bioidentity test, only one of these bioidentity tests is required.

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USP Dextrose RS
USP Glucagon (Human) RS
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