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 enumeration tests

and Tests for specified microorganisms

— 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— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Ian DeVeau, Ph.D. Director, Veterinary Drugs and Radiopharmaceuticals 1-301-816-8178	(RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
61	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance
62	Radhakrishna S Tirumalai, Ph.D. Senior Scientist 1-301-816-8339	(MSA05) Microbiology and Sterility Assurance

USP32–NF27 Page 1798

Pharmacopeial Forum: Volume No. 29(2) Page 441