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

USP Reference standards á11ñ— USP Endotoxin RS.

Completeness of solution á641ñ— A1.0-g portion dissolves in 10mLof carbon dioxide-free water to yield a clear solution.

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

Bacterial endotoxins á85ñ— It contains not more than 0.003USP Endotoxin Unit per mg of urea.

Other requirements— It responds to the Identificationtests and meets the requirements for Melting range,Residue on ignition,Alcohol-insoluble matter,Chloride,Sulfate,Heavy metals,and Assayunder Urea.It meets also the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.

Expert Committee:(PA5)Pharmaceutical Analysis 5

USP28–NF23Page 2006

Phone Number:1-301-816-8305