U.S. PHARMACOPEIA

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Urea C 13 for Oral Solution
» Urea C 13 for Oral Solution is a dry powder prepared from Urea C 13. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of urea C 13 (13CH4N2O). It contains no preservatives.
Packaging and storage— Preserve in sterile, well-closed containers.
Labeling— Label it to indicate that the solution is to be discarded if particulate matter is visible after reconstitution. [NOTE—It is to be reconstituted with Sterile Purified Water.]
Microbial limits 61— The total aerobic microbial count does not exceed 1000 cfu per g, the total combined molds and yeasts count does not exceed 100 cfu per g, and it meets the requirements for the absence of Salmonella species and Eschericha coli.
Completeness of solution 641: meets the requirements, a solution in carbon dioxide-free water containing 100 mg per mL being used.
Other requirements— It meets the requirements for Identification tests A and B under Urea and for the Assay under Urea C 13, and for packaged solids under Uniformity of Dosage Units 905.
Auxiliary Information— Staff Liaison : Andrzej Wilk, Ph.D., Senior Scientific Associate
Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
USP29–NF24 Page 384
Pharmacopeial Forum : Volume No. 29(2) Page 441
Phone Number : 1-301-816-8305