U.S. PHARMACOPEIA

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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 95.0 percent and not more than 105.0 percent 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85— It contains not more than 80 USP Endotoxin Units for each 100 USP Insulin Human Units.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Particulate matter 788: meets the requirements for small-volume injections.
Limit of high molecular weight proteins— Proceed as directed in the test for Limit of high molecular weight proteins under Insulin Injection: not more than 1.7% is found.
Other requirements— It meets the requirements under Injections 1 and for pH and Zinc content under Insulin Injection.
Assay—
Mobile phase, System suitability solution, and Chromatographic system— Proceed as directed in the Assay under Insulin.
Standard preparation—Prepare as directed in the Assay under Insulin Human.
Assay preparations— Prepare as directed in the Assay under Insulin Injection.
Procedure— Separately inject equal volumes (about 20 µL) of the appropriate Assay preparation and the Standard preparation into the chromatograph, record the chromatograms, and measure the peak responses for insulin and A-21 desamido insulin. Calculate the potency, in USP Insulin Human Units per mL, of the Injection taken by the formula:
(CD)(SrU / SrS),
in which C is the concentration, in USP Insulin Human Units per mL, of USP Insulin Human RS in the Standard preparation; D is the dilution factor; and SrU and SrS are the sums of the areas of the insulin and A-21 desamido insulin peaks obtained from the chromatograms of 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 1136
Pharmacopeial Forum : Volume No. 30(5) Page 1630
Phone Number : 1-301-816-8385