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Urea for Injection
» Urea for Injection is Urea suitable for parenteral use.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1 .
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.
(Official January 1, 2007)
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.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (MDCV05) Monograph Development-Cardiovascular
USP29–NF24 Page 2231
Phone Number : 1-301-816-8305