Extended Insulin Zinc Suspension
»Extended 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 is predominantly crystalline.Its potency,based on the sum of its insulin and desamido insulin components,is not less than 95.0percent and not more than 105.0percent of the potency stated on the label,expressed in USP Insulin Units per mL.
Packaging and storage— Preserve in the unopened multiple-dose container provided by the manufacturer.Do not repackage.Store in a refrigerator,protect from sunlight,and avoid freezing.
Labeling— Label it to indicate the one or more animal species to which it is related,as porcine,as bovine,or as a mixture of porcine and bovine.Where it is purified,label it as such.Its container label states that the Suspension is to be shaken carefully before use.The label states the potency in USP Insulin Units per mL.Label it to state that it is to be stored in a refrigerator and that freezing is to be avoided.
Identification— It meets the requirements of the Identificationtest under Insulin Injection.
Bacterial endotoxins á85ñ— It contains not more than 80USP Endotoxin Units per 100USP Insulin Units.
pHá791ñ: between 7.0and 7.8,determined potentiometrically.
Insulin not extracted by buffered acetone solution— Proceed as directed under Insulin Zinc Suspension:the insulin concentration,determined by an appropriate method,is not less than 90%of the insulin content of an equal amount of the Suspension.
Limit of high molecular weight proteins— Proceed as directed in the test for Limit of high molecular weight proteinsunder Insulin Injection:not more than 1.5%is found.
Other requirements— It meets the requirements in the tests for Sterilityand Insulin in the supernatantunder Isophane Insulin Suspensionand for Zinc contentand Zinc in the supernatantunder Insulin Zinc Suspension.
Assay— Proceed as directed in the Assayunder Insulin Injection.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1026
Pharmacopeial Forum:Volume No.27(2)Page 2169
Phone Number:1-301-816-8385