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
.
1.
USP Reference standards 11—
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.
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.
1.
Bacterial endotoxins 85—
It contains not more than 0.003 USP Endotoxin Unit per mg of urea.
85—
It contains not more than 0.003 USP Endotoxin Unit per mg of urea.
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.
71, Uniformity of Dosage Units 905, and Labeling under Injections 1.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Sujatha Ramakrishna, Ph.D.
Senior Scientific Liaison 1-301-816-8349 |
(SM22010) Monographs - Small Molecules 2 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4979