Isophane Insulin Human Suspension
»Isophane Insulin Human Suspension is a sterile suspension of zinc-insulin human crystals and Protamine Sulfate in buffered Water for Injection,combined in a manner such that the solid phase of the suspension consists of crystals composed of insulin human,protamine,and zinc.The Protamine Sulfate is prepared from the sperm or from the mature testes of fish belonging to the genus OncorhynchusSuckley,or SalmoLinné(Fam.Salmonidae).Its potency,based on the sum of its insulin and desamido insulin components,as in the Assay,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— The Suspension container label states that the Suspension is to be shaken carefully before use.The labeling states also 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.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 Units per mL.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 80USP Endotoxin Units per 100USP Insulin Human Units.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,and the Suspension being filtered immediately after it has been reduced to a clear solution by the addition of a freshly prepared 1in 100solution of ascorbic acid in Fluid A.
pHá791ñ: between 7.0and 7.5,determined potentiometrically.
Zinc content á591ñ: between 0.021mg and 0.04mg for each 100USP Insulin Human Units.
Insulin in the supernatant—
Test solution— Centrifuge 10mLof the Suspension at 1500×gfor 10minutes.Use the supernatant.
Procedure— Determine the insulin content of the Test solutionby a suitable method:the insulin concentration is not more than 1.0USP Insulin Human Unit per mL.
Limit of high molecular weight proteins— Proceed as directed in the test for Limit of high molecular weight proteinsunder Insulin Injection:not more than 3.0%is found.
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 1025
Pharmacopeial Forum:Volume No.27(2)Page 2169
Phone Number:1-301-816-8385