DEFINITION

Isophane Insulin Human Suspension is a sterile suspension of zinc–insulin human crystals and Protamine Sulfate in buffered Water for Injection, combined in a manner such that the solid phase of the suspension consists of crystals composed of insulin human, protamine, and zinc. Protamine Sulfate is prepared from the sperm or from the mature testes of fish belonging to the genus Oncorhynchus Suckley, or Salmo L. (Fam. Salmonidae). Its potency, based on the sum of its insulin and desamido insulin components as determined in the Assay, is NLT 95.0% and NMT 105.0% of the potency stated on the label, expressed in USP Insulin Human Units/mL.