(tran'' ex am' ik as' id).
Cyclohexanecarboxylic acid, 4-(aminomethyl)-, trans [1197-18-8].
Tranexamic Acid contains NLT 99.0% and NMT 101.0% of C8H15NO2, calculated on the dried basis.
Sample solution: 140 mg of Tranexamic Acid in 20 mL of glacial acetic acid
(See Titrimetry 541.)
Mode: Direct titration
Titrant: 0.1 N perchloric acid VS
Endpoint detection: Potentiometric
Sample: Sample solution
Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Carry out a blank titration.
Each mL of 0.1 N perchloric acid is equivalent to 15.72 mg of C8H15NO2.
Acceptance criteria: 99.0%101.0% on the dried basis
• Residue on Ignition 281: NMT 0.1%; 1-g sample is used
• Heavy Metals, Method II 231: NMT 10 ppm
• Chloride and Sulfate, Chloride 221: A 0.51-g portion shows no more chloride than corresponds to 0.1 mL of 0.020 N hydrochloric acid (0.014%).
Mobile phase: Dissolve 11.0 g of anhydrous monobasic sodium phosphate in 500 mL of water, and add 5 mL of triethylamine, followed by 1.4 g of sodium lauryl sulfate. Adjust with diluted phosphoric acid (10% w/w) to a pH of 2.5, and dilute with water to 600 mL. Mix this solution with 400 mL of methanol.
System suitability solution: 0.2 mg/mL of USP Tranexamic Acid RS and 0.002 mg/mL of USP Tranexamic Acid Related Compound C RS in water
Standard solution: 50 µg/mL of USP Tranexamic Acid RS in water
Sample solution: 10 mg/mL of Tranexamic Acid in water
Detector: UV 220 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection size: 20 µL
Run time: 3 times the retention time of tranexamic acid
Sample: System suitability solution
Resolution: NLT 2.0 between tranexamic acid and 0.002 mg/mL of tranexamic acid related compound C
Samples: Standard solution and Sample solution
Calculate the percentage of each individual impurity in the portion of Tranexamic Acid taken:
Result = (rU/rS) × (CS/CU) × (0.1F)
Individual impurities: See Impurity Table 1.
Total impurities: NMT 0.2%
[NoteDisregard any peak less than 0.025%. ]
Impurity Table 1
• Loss on Drying 731: Dry 1.00 g at 105 under vacuum for 2 h. It loses NMT 0.5% of its weight.
• Packaging and Storage: Preserve in tight containers, and store at a temperature not exceeding 30.
• USP Reference Standards 11
USP Tranexamic Acid Related Compound C RS
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USP35NF30 Page 4911Pharmacopeial Forum: Volume No. 34(6) Page 1484