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Methenamine Mandelate Delayed-Release Tablets
» Methenamine Mandelate Delayed-Release Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of methenamine mandelate (C6H12N4·C8H8O3).
Packaging and storage— Preserve in well-closed containers.
Disintegration 701: 2 hours and 30 minutes, determined as directed under Delayed-release (enteric coated) Tablets.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Other requirements— Delayed-release Tablets respond to the Identification test and meet the requirements for Uniformity of dosage units and Assay under Methenamine Mandelate Tablets.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1378
Phone Number : 1-301-816-8394