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. [noteIt is to be reconstituted with Sterile Purified Water. ]
Microbial enumeration tests 61 and Tests for specified microorganisms 62 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.
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USP35NF30 Page 2496Pharmacopeial Forum: Volume No. 29(2) Page 441