Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.

USP Reference standards 11— USP Dextrose RS. USP Endotoxin RS. USP Glucagon RS.

Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.

Bacterial endotoxins 85— It contains not more than 125.0 USP Endotoxin Units per mg of glucagon.

pH and Clarity of solution— Dissolve it in the solvent and in the concentration recommended in the labeling: the pH of the solution is between 1.7 and 3.0, and the solution is clear.

Other requirements— Both Glucagon for Injection and the accompanying solvent meet the requirements for Sterility Tests 71 and Labeling under Injections 1. Glucagon for Injection meets the requirements under Uniformity of Dosage Units 905.

Assay— Proceed as directed for the Assay in Glucagon. The potency is not less than 80.0% and not more than 125.0% of the labeled amount of glucagon, and the confidence interval width at P = 0.95 does not exceed 45% of the computed potency. Repeat the Assay if the confidence interval width exceeds 45% of the computed potency or if the potency is less than 80.0% or more than 125.0% of the labeled amount of glucagon.

Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides

USP29–NF24 Page 1008

Phone Number : 1-301-816-8385