Extended Insulin Human Zinc Suspension
» Extended 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 is predominantly crystalline. Its potency, based on the sum of its insulin and desamido insulin components, is not less than 95.0 percent and not more than 105.0 percent of the potency stated on the label, expressed in USP Insulin Human 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 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
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.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3513Pharmacopeial Forum: Volume No. 27(2) Page 2170