Packaging and storage— Preserve in tight, light-resistant containers.

USP Reference standards 11— USP Sulfamethizole RS.

Identification— Place a quantity of Oral Suspension, equivalent to about 500 mg of sulfamethizole, in a 50-mL centrifuge tube; add about 30 mL of water; mix; and centrifuge the mixture. Decant and discard the supernatant. Resuspend the residue in 15 mL of water, mix, and centrifuge the mixture. Decant and discard the clear supernatant. Repeat the washing procedure an additional two times. Dissolve the residue in a mixture of 10 mL of 6 N ammonium hydroxide and 10 mL of water, and filter. Warm the filtrate until most of the ammonia is expelled, cool, and add 6 N acetic acid until the mixture is distinctly acid: a precipitate of sulfamethizole is formed. Collect the precipitate on a filter, wash it well with cold water, and dry at 105 for 2 hours: the sulfamethizole so obtained responds to Identification test A under Sulfamethizole.

Uniformity of dosage units 905—

Deliverable volume 698—

Residual solvents 467: meets the requirements.

Assay— Transfer an accurately measured volume of Oral Suspension, equivalent to about 500 mg of sulfamethizole, to a beaker. Add 50 mL of water and 20 mL of hydrochloric acid, stir until dissolved, cool to 15, and slowly titrate with 0.1 M sodium nitrite VS, determining the endpoint potentiometrically, using suitable electrodes. Each mL of 0.1 M sodium nitrite is equivalent to 27.03 mg of sulfamethizole (C9H10N4O2S2).

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

USP29–NF24 Page 2033

Phone Number : 1-301-816-8394