DEFINITION

Insulin Zinc Suspension is a sterile suspension of Insulin in buffered Water for Injection, modified by the addition of a suitable zinc salt in a manner such that the solid phase of the suspension consists of a mixture of crystalline and amorphous insulin in a ratio of approximately 7 parts of crystals to 3 parts of amorphous material. Its potency, based on the sum of its insulin and desamido insulin components, is NLT 95.0% and NMT 105.0% of the potency stated on the label, expressed in USP Insulin Units/mL.