DEFINITION

Insulin Human is a two-chain peptide hormone consisting of 51 amino acids, and its structure corresponds to native insulin produced in vivo by the beta cells of the pancreas. The A-chain is composed of 21 amino acids, and the B-chain is composed of 30 amino acids. It is either produced by methods based on recombinant DNA technology or derived by enzymatic modification of insulin from porcine pancreas to change the amino acid sequence appropriately. The presence of host cell DNA in Insulin Human is process-specific. The capability of the process to clear host-derived DNA requires validation and is determined by validated methods. Its potency is NLT 27.5 USP Insulin Human Units/mg, calculated on the dried basis.