Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.

USP Reference standards á11ñ— USP Dextrose RS.USP Endotoxin RS.USP Glucagon RS.

Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.

Bacterial endotoxins á85ñ— It contains not more than 125.0USP Endotoxin Units per mg of glucagon.

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

Other requirements— Both Glucagon for Injection and the accompanying solvent meet the requirements for Sterility Tests á71ñand Labelingunder Injections á1ñ.Glucagon for Injection meets the requirements under Uniformity of Dosage Units á905ñ.

Assay— Proceed as directed for the Assayin 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=0.95does not exceed 45%of the computed potency.Repeat the Assayif 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:(BNT)Biotechnology and Natural Therapeutics/Diagnostics

USP28–NF23Page 908

Phone Number:1-301-816-8385