DEFINITION

Insulin Glargine is a two-chain peptide containing 53 amino acids. The A-chain is composed of 21 amino acids, and the B-chain is composed of 32 amino acids. It is identical to the primary structure of Human Insulin except for position A21 which has Gly rather than Asn as in Human Insulin and two additional amino acids at the C terminal of the B-chain Arg (B31) and Arg (B32). Insulin Glargine is produced by methods based on recombinant DNA technology. Residual host cell protein (HCP) content is determined by a validated method and is NMT 10 ppm (ng HCP per mg of Insulin Glargine). Insulin Glargine contains NLT 94.0% and NMT 105.0% of insulin glargine (C₂₆₇H₄₀₄N₇₂O₇₈S₆), calculated on the anhydrous basis, or on the dried basis when other volatile solvents in addition to water are present.