Mitobronitol Tablets

General Notices

Action and use

Cytotoxic.

Definition

Mitobronitol Tablets contain Mitobronitol.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of mitobronitol, C6H12Br2O4

92.5 to 107.5% of the stated amount.

Identification

Extract a quantity of the powdered tablets containing 0.5 g of Mitobronitol with 10 mL of hot methanol, filter and allow the filtrate to cool. The crystalline precipitate, after filtering and drying at 105° for 2 hours, complies with the following tests.

A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of mitobronitol (RS 236).
B. Dissolve 0.1 g in 10 mL of 1m sodium hydroxide, boil, cool, acidify with 2m nitric acid and add 1 mL of silver nitrate solution. A pale yellow, curdy precipitate is produced.

Tests

Ionic halide

Shake a quantity of powdered tablets containing 1 g of Mitobronitol with 50 mL of water for 15 minutes, dilute to 100 mL with water and filter. To 50 mL of the filtrate add 10 mL of 2m nitric acid and 5 mL of 0.01m silver nitrate VS and mix. Titrate the excess of silver nitrate with 0.01m ammonium thiocyanate VS using ammonium iron(iii) sulfate solution R2 as indicator. Not more than 3.2 mL of 0.01m silver nitrate VS is required.

Assay

Weigh and powder 20 tablets. To a quantity of the powder containing 0.2 g of Mitobronitol add 40 mL of 0.5m sodium hydroxide, heat to boiling, cool, add 25 mL of 0.1m silver nitrate VS, acidify with 5 mL of 5m nitric acid and titrate the excess of silver nitrate with 0.1m ammonium thiocyanate VS determining the end point potentiometrically. Each mL of 0.1m silver nitrate VS is equivalent to 15.40 mg of C6H12Br2O4.

Storage

Mitobronitol Tablets should be protected from light.