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

USP Reference standards 11— USP Endotoxin RS.

Completeness of solution 641— A 1.0-g portion dissolves in 10 mL of carbon dioxide-free water to yield a clear solution.

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 0.003 USP Endotoxin Unit per mg of urea.

Residual solvents 467: meets the requirements.

Other requirements— It responds to the Identification tests and meets the requirements for Melting range, Residue on ignition, Alcohol-insoluble matter, Chloride, Sulfate, Heavy metals, and Assay under Urea. It meets also the requirements for Sterility Tests 71 , Uniformity of Dosage Units 905 , and Labeling under Injections 1.

Expert Committee : (MDCV05) Monograph Development-Cardiovascular

USP29–NF24 Page 2231

Phone Number : 1-301-816-8305