Related substances—Conduct this pro

Related substances—Conduct this procedure using light-resistant vessels. Dissolve 50mg of Terbinafine Hydrochloride in 100 mL of a mixture of water and acetonitrile (1:1), and use this solution as the sample solution. Pipet 1mL of the sample solution, and add a mixture of water and acetonitrile (1:1) to make exactly 100 mL. Pipet 5 mL of this solution, add a mixture of water and acetonitrile (1:1) to make exactly 50 mL, and use this solution as the standard solution. Perform the test with exactly 20 mL each of the sample solution and standard solution as directed under Liquid Chromatography according to the following conditions, and determine each peak area by the automatic integration method: the peak area of a dimer, having the relative retention time of about 1.7 to terbinafine obtained from the sample solution is not larger than 1/2 times the peak area of terbinafine from the standard solution, the area of the peaks other than terbinafine and the dimer from the sample solution is not larger than the peak area of terbinafine from the standard solution, and the total area of the peaks other than terbinafine is not larger than 3 times the peak area of terbinafine from the standard solution.