Trichloroacetic Acid Solution

Trichloroacetic Acid Cutaneous Solution

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

Used in the treatment of warts.

Trichloroacetic Acid Solution is a cutaneous solution. It contains Trichloroacetic Acid in Purified Water.

The solution complies with the requirements stated under Liquids for Cutaneous Application, the requirements stated under Unlicensed Medicines and with the following requirements.

95.0 to 105.0% of the stated amount.

A. Dilute a quantity of the solution with sufficient water to produce a solution containing 10% w/v of Trichloroacetic Acid. To 0.5 mL of this solution add 2 mL of pyridine and 5 mL of strong sodium hydroxide solution. Shake vigorously and heat in a water-bath at 60° to 70° for 5 minutes; the upper layer shows an intense red colour.

B. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).

Dilute a quantity of the solution with sufficient water to produce a solution containing 10% w/v of Trichloroacetic Acid and dilute 5 mL of this solution to 15 mL with water. The resulting solution complies with the limit test for chlorides, Appendix VII (100 ppm).

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) Dilute a quantity of the solution with sufficient water to produce a solution containing 0.18% w/v of Trichloroacetic Acid.

(2) 0.18% w/v of trichloroacetic acid BPCRS in water.

(a) Use a stainless steel column (10 cm × 4.6 mm) packed with octylsilyl silica gel for chromatography (3 µm) (Waters Spherisorb S3 C8 is suitable).

(b) Use isocratic elution and the mobile phase described below.

(c) Use a flow rate of 1.4 mL per minute.

(d) Use an ambient column temperature.

(e) Use a detection wavelength of 230 nm.

(f) Inject 20 µL of each solution.

0.01m orthophosphoric acid.

Calculate the content of C₂HCl₃O₂ in the solution using the declared content of C₂HCl₃O₂ in trichloroacetic acid BPCRS.

Trichloroacetic Acid Solution should be protected from light.