Methenamine Mandelate for Oral Solution
» Methenamine Mandelate for Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of methenamine mandelate (C6H12N4·C8H8O3).
Packaging and storage— Preserve in well-closed containers.
Labeling— Label Methenamine Mandelate for Oral Solution that contains insoluble ingredients to indicate that the aqueous constituted Oral Solution contains dissolved methenamine mandelate, but may remain turbid because of the presence of added substances.
USP Reference standards 11
USP Methenamine Mandelate RS Click to View Structure
Identification— A finely powdered portion, equivalent to about 100 mg of methenamine mandelate, responds to the Identification test under Methenamine Mandelate Oral Suspension.
Uniformity of dosage units 905
for powder packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for powder packaged in multiple-unit containers: meets the requirements.
pH 791: between 4.0 and 4.5, in a mixture of 1 g with 30 mL of water.
Water, Method I 921: not more than 0.5%.
Assay— Accurately weigh the contents of not fewer than 10 containers of Methenamine Mandelate for Oral Solution, and reduce to a fine powder. Transfer an accurately weighed portion of the powder, equivalent to about 60 mg of methenamine mandelate, to a 150-mL beaker. Add 15 mL of dehydrated alcohol, stir to dissolve, and proceed as directed in the Assay under Methenamine Mandelate, beginning with “add 40 mL of chloroform.”
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Leonel M. Santos, Ph.D.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
Reference Standards RS Technical Services
USP35–NF30 Page 3849
Pharmacopeial Forum: Volume No. 29(6) Page 1930