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.

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—

Deliverable volume 698

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%.

Residual solvents 467: meets the requirements.

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.”

Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials

USP29–NF24 Page 1377

Phone Number : 1-301-816-8394