Insulin Human Zinc Suspension
»Insulin Human Zinc Suspension is a sterile suspension of Insulin Human 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 7parts of crystals to 3parts of amorphous material.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 Human Units in each 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 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.
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 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 Identification,Sterility,and Insulin in the supernatantunder Isophane Insulin Human Suspensionand for Zinc content,Zinc in the supernatant,and Insulin not extracted by buffered acetone solutionunder Insulin Zinc Suspension.
Assay— Proceed as directed in the Assayunder Insulin Human Injection.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1027
Pharmacopeial Forum:Volume No.27(2)Page 2170
Phone Number:1-301-816-8385