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 that it has been prepared with Insulin Human of semisynthetic origin (i.e.,derived by enzyme modification of pork pancreas insulin)or with Insulin Human of recombinant DNAorigin (i.e.,obtained from microbial synthesis),whichever is applicable.The Suspension container label states that the Suspension is to be shaken carefully before use.Label it to state that it is to be stored in a refrigerator and that freezing is to be avoided.The label states the potency in USP Insulin Human Units per mL.

USP Reference standards á11ñ— USP Endotoxin RS.USP Insulin Human RS.USP Insulin (Pork)RS.

Bacterial endotoxins á85ñ— It contains not more than 80USP Endotoxin Units per 100USP Insulin Human Units.

pHá791ñ: between 7.0and 7.8,determined potentiometrically.

Limit of high molecular weight proteins— Proceed as directed in the Limit of high molecular weight proteinstest under Insulin Injection:not more than 1.5%is found.

Other requirements— It meets the requirements in the tests for Identification,Sterility,and Insulin in the supernatantunder Isophane Insulin Human Suspension,for Zinc contentand Zinc in the supernatantunder Insulin Zinc Suspension,and for Insulin not extracted by buffered acetone solutionunder Extended Insulin Zinc Suspension.

Assay— Proceed as directed in the Assayunder Insulin Human Injection.

Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics

USP28–NF23Page 1027

Phone Number:1-301-816-8385