Urea C13for Oral Solution
»Urea C13for Oral Solution is a dry powder prepared from Urea C13.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of urea C13(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 á61ñ— The total aerobic microbial count does not exceed 1000cfu per g,the total combined molds and yeasts count does not exceed 100cfu per g,and it meets the requirements for the absence of Salmonellaspecies and Eschericha coli.
Completeness of solution á641ñ: meets the requirements,a solution in carbon dioxide-free water containing 100mg per mLbeing used.
Other requirements— It meets the requirements for Identificationtests Aand Bunder Ureaand for the Assayunder Urea C13,and for packaged solids under Uniformity of Dosage Units á905ñ.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 355
Pharmacopeial Forum:Volume No.29(2)Page 441
Phone Number:1-301-816-8305