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 DNA origin (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 11— USP Endotoxin RS. USP Insulin Human RS. USP Insulin (Pork) RS.

Bacterial endotoxins 85— It contains not more than 80 USP Endotoxin Units per 100 USP Insulin Human Units.

pH 791: between 7.0 and 7.8, determined potentiometrically.

Limit of high molecular weight proteins— Proceed as directed in the Limit of high molecular weight proteins test 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 supernatant under Isophane Insulin Human Suspension, for Zinc content and Zinc in the supernatant under Insulin Zinc Suspension, and for Insulin not extracted by buffered acetone solution under Extended Insulin Zinc Suspension.

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

Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides

USP29–NF24 Page 1140

Phone Number : 1-301-816-8385