Insulin Lispro Injection
»Insulin Lispro Injection is an isotonic,sterile solution of Insulin Lispro 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 as USP Insulin Lispro Units in each mL.
Packaging and storage— Preserve in tight,multiple-dose containers,and store in a refrigerator.Avoid freezing.Protect from sunlight.Dispense it in the unopened,multiple-dose container provided by the manufacturer.
Labeling— The labeling states that it has been prepared with Insulin Lispro obtained from microbial synthesis.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 Lispro 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: not more than 80USP Endotoxin Units per 100USP Insulin Lispro Units,the kinetic-chromogenic method under Photometric Techniquesbeing used.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pHá791ñ: between 7.0and 7.8.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Limit of high molecular weight proteins—
Arginine solution,Mobile phase,Resolution solution,Test solution,andChromatographic system— Proceed as directed in the test for Limit of high molecular weight proteinsunder Insulin Injection.
Procedure— Proceed as directed for Procedurein the test for Limit of high molecular weight proteinsunder Insulin:not more than 1.50%is found.
Related compounds—
Test solution— Acidify each mLof Injection with 3µLof 9.6Nhydrochloric acid.
Solvent,System suitability solution,Mobile phase,Chromatographic system,andProcedure— Proceed as directed in the test for Related compoundsunder Insulin Lispro.Not more than 1.50%A-21desamido insulin lispro is found;and not more than 4.00%of total impurities,excluding A-21desamido insulin lispro,is found.
Zinc content á591ñ: between 14and 35µg for each 100USP Insulin Lispro Units.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Solvent,Mobile phase,System suitability solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Insulin Lispro.
Assay preparation— Acidify each mLof Injection with 3µLof 9.6Nhydrochloric acid.Quantitatively dilute a portion of the acidified solution with 0.01Nhydrochloric acid to obtain a solution containing about 20USP Insulin Lispro Units per mL.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the potency,in USP Insulin Lispro Units,in each mLof the Injection taken by the formula:
CD(rU/rS),
in which Cis the concentration,in USP Insulin Lispro Units per mL,of USP Insulin Lispro RSin the Standard preparation;Dis the dilution factor used to prepare theAssay preparation;and rUand rSare the insulin lispro peak areas obtained from 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 1024
Pharmacopeial Forum:Volume No.28(4)Page 1128
Phone Number:1-301-816-8385