Methenamine Mandelate Delayed-Release Tablets, chemical structure, molecular formula, Reference Standards

Methenamine Mandelate Delayed-Release Tablets

»Methenamine Mandelate Delayed-Release Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of methenamine mandelate (C6H12N4·C8H8O3).

Packaging and storage— Preserve in well-closed containers.

USP Reference standards á11ñ— USP Methenamine Mandelate RS.

Disintegration á701ñ: 2hours and 30minutes,determined as directed under Delayed-release (enteric coated)Tablets.

Other requirements— Delayed-release Tablets respond to the Identificationtest and meet the requirements for Uniformity of dosage unitsand Assayunder Methenamine Mandelate Tablets.

Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1244

Phone Number:1-301-816-8394