Insulin Human Injection
»Insulin Human Injection is an isotonic sterile solution of Insulin Human in Water for Injection.It has a potency of 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 a refrigerator.Protect from sunlight.Avoid freezing.Dispense it in the unopened,multiple-dose container in which it was placed by the manufacturer.
Labeling— The labeling states that it has been prepared either with Insulin Human derived by enzyme modification of pork pancreas Insulin or with Insulin Human 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 Human 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 for each 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.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñand for pH,Zinc content,and Limit of high molecular weight proteinsunder Insulin Injection.
Assay—
Mobile phase,System suitability solution,and Chromatographic system— Proceed as directed in the Assayunder Insulin.
Standard preparation—Prepare as directed in the Assayunder Insulin Human.
Assay preparations— Prepare as directed in the Assayunder Insulin Injection.
Procedure— Separately inject equal volumes (about 20µL)of the appropriate Assay preparationand the Standard preparationinto the chromatograph,record the chromatograms,and measure the peak responses for insulin and A-21desamido insulin.Calculate the potency,in USP Insulin Human Units per mL,of the Injection taken by the formula:
(CD)(SrU/SrS),
in which Cis the concentration,in USP Insulin Human Units per mL,of USP Insulin Human RSin the Standard preparation;Dis the dilution factor;and SrUand SrSare the sums of the areas of the insulin and A-21desamido insulin peaks obtained from the chromatograms of the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Larry N.Callahan,Ph.D.,Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 1023
Pharmacopeial Forum:Volume No.30(5)Page 1630
Phone Number:1-301-816-8385