Methenamine Mandelate Oral Suspension
» Methenamine Mandelate Oral Suspension is Methenamine Mandelate suspended in vegetable oil. It 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 tight containers.
Identification— Triturate a quantity, equivalent to about 100 mg of methenamine mandelate, with 10 mL of chloroform, and pass through a 0.45-µm membrane filter. Evaporate the solvent, wash the residue with 5 small portions of ether, and allow it to air-dry: the IR absorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of a potassium bromide dispersion of USP Methenamine Mandelate RS.
Uniformity of dosage units 905
for oral suspension packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for oral suspension packaged in multiple-unit containers: meets the requirements.
Water, Method I 921: not more than 0.1%.
Assay— Shake the Oral Suspension, then pipet, using a “to contain” pipet, an amount equivalent to 1 g of methenamine mandelate, into a 100-mL volumetric flask. Add 5.0 mL of dehydrated alcohol, mix, and add methylene chloride to volume. Pipet 5 mL of this solution into a 250-mL conical flask. Add 15 mL of dehydrated alcohol, 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 Behnam Davani, Ph.D., M.B.A.
Senior Scientist
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2923
Pharmacopeial Forum: Volume No. 29(6) Page 1930