Tranexamic Acid Mouthwash

note: Tranexamic Acid Mouthwash is not currently licensed in the United Kingdom.

Antifibrinolytic.

Tranexamic Acid Mouthwash contains Tranexamic Acid in a suitable vehicle.

The mouthwash complies with the requirements stated under Oromucosal Preparations, the requirements stated under Unlicensed Medicines and with the following requirements.

95.0 to 105.0% of the stated amount.

To a volume of the mouthwash containing 0.25 g of Tranexamic Acid add 25 mL of ethanol (96%) and shake mechanically for 15 minutes; a cloudy white solution is produced, which may contain white lumps. Remove any lumps and filter the remaining solution using a glass fibre filter (Whatman GF/C filter is suitable). Wash the residue with 50 mL of ethanol (96%) and dry under vacuum at 35° for 30 minutes. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of tranexamic acid (RS 344).

pH, 6.5 to 8.0, Appendix V L.

To a volume of the mouthwash containing 0.1 g of Tranexamic Acid add 50 mL of water and adjust the pH of the solution to 7.0 with either 0.1m sodium hydroxide or 0.1m hydrochloric acid. Add 25 mL of formaldehyde solution, previously adjusted to pH 7.0, and 20 mL of 0.1m sodium hydroxide VS. Titrate immediately with 0.1m hydrochloric acid VS, determining the end point potentiometrically. Repeat the operation without the preparation being examined. The difference between the titrations represents the amount of sodium hydroxide required. Each mL of 0.1m sodium hydroxide VS is equivalent to 15.72 mg of C₈H₁₅NO₂.