U.S. PHARMACOPEIA

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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 95.0 percent and not more than 105.0 percent 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85: not more than 80 USP Endotoxin Units per 100 USP Insulin Lispro Units, the kinetic-chromogenic method under Photometric Techniques being used.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 7.0 and 7.8.
Particulate matter 788: meets the requirements for small-volume injections.
Limit of high molecular weight proteins—
Arginine solution, Mobile phase, Resolution solution, Test solution, and Chromatographic system— Proceed as directed in the test for Limit of high molecular weight proteins under Insulin Injection.
Procedure— Proceed as directed for Procedure in the test for Limit of high molecular weight proteins under Insulin: not more than 1.50% is found.
Related compounds—
Test solution— Acidify each mL of Injection with 3 µL of 9.6 N hydrochloric acid.
Solvent, System suitability solution, Mobile phase, Chromatographic system, and Procedure— Proceed as directed in the test for Related compounds under Insulin Lispro. Not more than 1.50% A-21 desamido insulin lispro is found; and not more than 4.00% of total impurities, excluding A-21 desamido insulin lispro, is found.
Zinc content 591: between 14 and 35 µg for each 100 USP Insulin Lispro Units.
Other requirements— It meets the requirements under Injections 1.
Assay—
Solvent, Mobile phase, System suitability solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Insulin Lispro.
Assay preparation— Acidify each mL of Injection with 3 µL of 9.6 N hydrochloric acid. Quantitatively dilute a portion of the acidified solution with 0.01 N hydrochloric acid to obtain a solution containing about 20 USP Insulin Lispro Units per mL.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas for the major peaks. Calculate the potency, in USP Insulin Lispro Units, in each mL of the Injection taken by the formula:
CD(rU / rS),
in which C is the concentration, in USP Insulin Lispro Units per mL, of USP Insulin Lispro RS in the Standard preparation; D is the dilution factor used to prepare the Assay preparation; and rU and rS are the insulin lispro peak areas obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 1137
Pharmacopeial Forum : Volume No. 28(4) Page 1128
Phone Number : 1-301-816-8385