NOTE: This monograph has been developed to cover unlicensed formulations.
Action and use
Antifibrinolytic.
DEFINITION
Tranexamic Acid Mouthwash contains Tranexamic Acid in a suitable vehicle.
The mouthwash complies with the requirements stated under Oromucosal Preparations and with the following requirements. Where appropriate, the mouthwash also complies with the requirements stated under Unlicensed Medicines.
Content of tranexamic acid, C8H15NO2
95.0 to 105.0% of the stated amount.
IDENTIFICATION
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).
TESTS
Acidity or alkalinity
pH, 6.5 to 8.0, Appendix V L.
ASSAY
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.
