Methenamine Mandelate Oral Suspension
»Methenamine Mandelate Oral Suspension is Methenamine Mandelate suspended in vegetable oil.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of methenamine mandelate (C6H12N4·C8H8O3).
Packaging and storage— Preserve in tight containers.
Identification— Triturate a quantity,equivalent to about 100mg of methenamine mandelate,with 10mLof chloroform,and pass through a 0.45-µm membrane filter.Evaporate the solvent,wash the residue with 5small portions of ether,and allow it to air-dry:the IRabsorption 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 á905ñ—
FOR ORAL SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ—
FOR ORAL SUSPENSION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
Water,Method Iá921ñ: not more than 0.1%.
Assay— Shake the Oral Suspension,then pipet,using a “to contain”pipet,an amount equivalent to 1g of methenamine mandelate,into a 100-mLvolumetric flask.Add 5.0mLof dehydrated alcohol,mix,and add methylene chloride to volume.Pipet 5mLof this solution into a 250-mLconical flask.Add 15mLof dehydrated alcohol,and proceed as directed in the Assayunder Methenamine Mandelate,beginning with “add 40mLof chloroform.”
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1243
Pharmacopeial Forum:Volume No.29(6)Page 1930
Phone Number:1-301-816-8394