Urea for Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Urea for Injection is Urea suitable for parenteral use.
Packaging and storage—Preserve as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution.
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 Injections and Implanted Drug Products 〈1〉, Specic Tests, Completeness and clarity of solutions.
Bacterial Endotoxins Test 〈85〉 —It contains not more than 0.003 USP Endotoxin Unit per mg of urea.
Other requirements—It responds to the Identication tests and meets the requirements for Melting range, Residue on ignition, Alcohol-insoluble matter, Chloride, Sulfate, and Assay under Urea. It meets also the requirements for Sterility Tests 〈71〉, Uniformity of Dosage Units 〈905〉, and
Labeling 〈7〉, Labels and Labeling for Injectable Products.
