JP XV

the isooctane-carbon disulfide mixture layer, and dehydrate with anhydrous sodium sulfate. Perform the test with these solutions as directed under Ultraviolet-visible Spectrophotometry <2.24>: the absorbance of the sample solution at 438 nm is not more than that of the standard solution. Loss on drying <2.41> silica gel, 3 hours). Not more than 0.5z (1 g, in vacuum, Not more than 0.1z (1 g).

Ocial Monographs / Tranexamic Acid

1191

Residue on ignition <2.44>

Assay Weigh accurately about 0.5 g of Tolperisone Hydrochloride, previously dried, dissolve in 70 mL of a mixture of acetic anhydride and acetic acid (100) (7:3), and titrate <2.50> with 0.1 mol W L perchloric acid VS (potentiometric titration). Perform a blank determination, and make any necessary correction. Each mL of 0.1 mol W L perchloric acid VS 28.18 mg C16H23NO.HCl Containers and storage ers. ContainersWell-closed contain-

Tranexamic Acid

C8H15NO2: 157.21 trans-4-(Aminomethyl)cyclohexanecarboxylic acid [1197-18-8 ]

Tranexamic Acid, when dried, contains not less than 98.0z and not more than 101.0z of C8H15NO2.
Description Tranexamic Acid occurs as white crystals or crystalline powder. It is freely soluble in water, and practically insoluble in ethanol (99.5). Identication Determine the infrared absorption spectrum of Tranexamic Acid as directed in the potassium bromide disk method under Infrared Spectrophotometry <2.25>, and compare the spectrum with the Reference Spectrum or the spectrum of Tranexamic Acid Reference Standard: both spectra exhibit similar intensities of absorption at the same wave numbers. pH <2.54> The pH of a solution prepared by dissolving 1.0 g of Tranexamic Acid in 20 mL of water is between 7.0 and 8.0. Purity (1) Clarity and color of solutionDissolve 1.0 g of Tranexamic Acid in 10 mL of water: the solution is clear and colorless. (2) Chloride <1.03>Perform the test with 1.0 g of Tranexamic Acid. Prepare the control solution with 0.40 mL of 0.01 mol/L hydrochloric acid VS (not more than 0.014z). (3) Heavy metalsDissolve 2.0 g of Tranexamic Acid in water to make 20 mL, and use this solution as the sample stock solution. To 12 mL of the sample stock solution add 2 mL of hydrochloric acid-ammonium acetate buer solu-

tion, pH 3.5, mix, add 1.2 mL of thioacetamide TS , mix immediately, and use this solution as the sample solution. Separately, proceed in the same manner as above with a mixture of 1 mL of Standard Lead Solution, 2 mL of the sample stock solution and 9 mL of water, and use the solution so obtained as the standard solution. Separately, proceed in the same manner with a mixture of 10 mL of water and 2 mL of the sample stock solution, and use the solution so obtained as the control solution. Conform that the color of the standard solution is slightly darker than that of the control solution. Compare the sample solution and the standard solution 2 minutes after they are prepared: the color of the sample solution is not more intense than that of the standard solution (not more than 10 ppm). (4) Arsenic <1.11>Prepare the test solution by dissolving 1.0 g of Tranexamic Acid in 10 mL of water, and perform the test (not more than 2 ppm). (5) Related substancesDissolve 0.20 g of Tranexamic Acid in water to make exactly 20 mL, and use this solution as the sample solution. Pipet 5 mL of the sample solution, and add water to make exactly 100 mL. Pipet 1 mL of this solution, add water to make exactly 10 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 <2.01> according to the following conditions, and determine each peak area by the automatic integration method: the area multiplied by relative response factor 1.2 of the peak, having the relative retention time of about 1.5 with respect to tranexamic acid, is not more than 2/5 of the peak area of tranexamic acid from the standard solution, and the area of the peak, having the relative retention time of about 2.1 with respect to tranexamic acid, is not more than 1/5 of the peak area of tranexamic acid from the standard solution. The area of each peak other than tranexamic acid and other than the peaks mentioned above is not more than 1/5 of the peak area of tranexamic acid from the standard solution. For this comparison, use the area of the peaks, having the relative retention time of about 1.1 and about 1.3, after multiplying by their relative response factors 0.005 and 0.006, respectively. The total area of the peaks other than tranexamic acid is not more than the peak area of tranexamic acid from the standard solution. Operating conditions Detector, column, column temperature, mobile phase, and ow rate: Proceed as directed in the operating conditions in the Assay. Time span of measurement: About 3 times as long as the retention time of tranexamic acid beginning after the solvent peak. System suitability Test for required detectability: To exactly 5 mL of the standard solution add water to make exactly 25 mL. Conrm that the peak area of tranexamic acid obtained from 20 mL of this solution is equivalent to 14 to 26z of that from 20 mL of the standard solution. System performance: Proceed as directed in the system suitability in the Assay. System repeatability: When the test is repeated 6 times with 20 mL of the standard solution under the above operating conditions, the relative standard deviation of the peak area of tranexamic acid is not more than 7z. Loss on drying <2.41> Not more than 0.5z (1 g, 1059 C,

1192
2 hours).

Tranexamic Acid Capsules / Ocial Monographs

velops. Not more than 0.1z (1 g). Uniformity of dosage units <6.02> of the Mass variation test.

JP XV

Residue on ignition <2.44>

It meets the requirement

Assay Weigh accurately about 50 mg each of Tranexamic Acid and Tranexamic Acid Reference Standard, previously dried, dissolve in water to make exactly 25 mL, and use these solutions as the sample solution and standard solution. Perform the test with exactly 20 mL each of the sample solution and standard solution as directed under Liquid Chromatography <2.01> according to the following conditions, and determine the peak areas, AT and AS, of tranexamic acid. Amount (mg) of C8H15NO2WS(AT/AS)

WS: Amount (mg) of Tranexamic Acid Reference Standard Operating conditions Detector: An ultraviolet absorption photometer (wavelength: 220 nm). Column: A stainless steel column 6.0 mm in inside diameter and 25 cm in length, packed with octadecylsilanized silica gel for liquid chromatography (5 mm in particle diameter). Column temperature: A constant temperature of about 259 C. Mobile phase: Dissolve 11.0 g of sodium dihydrogen phosphate in 500 mL of water, and add 5 mL of triethylamine and 1.4 g of sodium lauryl sulfate. Adjust the pH to 2.5 with phosphoric acid or diluted phosphoric acid (1 in 10), add water to make 600 mL, and add 400 mL of methanol. Flow rate: Adjust the ow rate so that the retention time of tranexamic acid is about 20 minutes. System suitability System performance: To 5 mL of the standard solution add 1 mL of a solution of 4-(aminomethyl)benzoic acid (1 in 10,000) and water to make 50 mL. When the procedure is run with 20 mL of this solution under the above operating conditions, tranexamic acid and 4-(aminomethyl)benzoic acid are eluted in this order with the resolution between these peaks being not less than 5. System repeatability: When the test is repeated 6 times with 20 mL of the standard solution under the above operating conditions, the relative standard deviation of the peak area of tranexamic acid is not more than 0.6z.
Containers and storage ers. ContainersWell-closed contain-

Dissolution <6.10> Perform the test according to the following method: it meets the requirement. Perform the test with 1 capsule of Tranexamic Acid Capsules at 50 revolutions per minute according to the Paddle methed using a sinker and using 900 mL of water as the dissolution medium. Withdraw 20 mL or more of the dissolved solution 15 minutes after starting the test, and lter through a membrane lter with pore size of not more than 0.45 mm. Discard the rst 10 mL of the ltrate, pipet the subsequent V mL, add water to make exactly V? mL so that each mL contains about 0.28 mg of tranexamic acid (C8H15NO2) according to the labeled amount, and use this solution as the sample solution. Separately, weigh accurately about 28 mg of Tranexamic Acid Reference Standard, previously dried at C for 2 hours, dissolve in water to make exactly 100 mL, 1059 and use this solution as the standard solution. Perform the test with exactly 10 mL each of the sample solution and standard solution as directed under Liquid Chromatography <2.01> according to the following conditions, and determine the peak areas of tranexamic acid, AT and AS. The dissolution rate in 15 minutes is not less than 80z. Dissolution rate (z) with respect to the labeled amount of tranexamic acid (C8H15NO2) WS(AT/AS)(V?/V)(1/C)900

WS: Amount (mg) of Tranexamic Acid Reference Standard C: Labeled amount (mg) of tranexamic acid (C8H15NO2) in 1 capsule Operating conditions Detector: An ultraviolet absorption photometer (wavelength: 220 nm). Column: A stainless steel column 4.6 mm in inside diameter and 15 cm in length, packed with octadecylsilanized silica gel for liquid chromatography (5 mm in particle diameter). Column temperature: A constant temperature of about 259 C. Mobile phase: Dissolve 11.0 g of anhydrous sodium dihydrogen phosphate in 500 mL of water, and add 10 mL of triethylamine and 1.4 g of sodium lauryl sulfate. Adjust the pH to 2.5 with phosphoric acid, add water to make 600 mL, and add 400 mL of methanol. Flow rate: Adjust the ow rate so that the retention time of tranexamic acid is about 8 minutes. System suitability System performance: When the procedure is run with 10 mL of the standard solution under the above operating conditions, the number of theoretical plates and the symmetry factor of the peak of tranexamic acid are not less than 4000 and not more than 2.0, respectively. System repeatability: When the test is repeated 6 times with 10 mL of the standard solution under the above operating conditions, the relative standard deviation of the peak area of tranexamic acid is not more than 2.0z.
Assay Weigh accurately the mass of the contents of not less than 20 Tranexamic Acid Capsules, and powder. Weigh accurately an amount of the powder, equivalent to about 0.1 g

Tranexamic Acid Capsules

Tranexamic Acid Capsules contain not less than 95.0z and not more than 105.0z of the labeled amount of tranexamic acid (C8H15NO2: 157.21).
Method of preparation Prepare as directed under Capsules, with Tranexamic Acid. Identication Take an amount of powdered contents of Tranexamic Acid Capsules, equivalent to 0.5 g of Tranexamic Acid according to the labeled amount, add 50 mL of water, shake well, and lter. To 5 mL of the ltrate add 1 mL of ninhydrin TS, and heat for 3 minutes: a dark purple color de-