USP 38 monograph: impurity analysis of tranexamic acid using a C18 HPLC column

Instrument Type: Unspecified

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the impurity analysis of tranexamic acid. The analysis was performed on a Thermo Scientific Acclaim 120 C18 HPLC column using the method described in the USP 38 monograph. Resolution between tranexamic acid and impurity C was 3.9 (exceeding USP criteria of not less than 2.0).

EP 8.0 monograph: impurity analysis of tranexamic acid using a C18 HPLC column

Instrument Type: HPLC

The Thermo Scientific Dionex UltiMate 3000 LC system is applied for the impurity analysis of tranexamic acid. The analysis was performed on a Thermo Scientific Hypersil GOLD HPLC column using the method described in the EP 8.0 monograph. Resolution between tranexamic acid and impurity C in reference solution (b) was 3.5 (exceeding EP criteria of minimum 1.5). Relative retention time of impurity C, D and B with reference to tranexamic acid was 1.15, 1.22 and 1.54 minute respectively (meeting EP criteria about 1.1, 1.3 and 1.5 min respectively for impurity C, D and B ).

Determincation of tranexamic acid according to the British Pharmacopoeia (BP) method using HPLC-UV

Instrument Type: HPLC

In this work the separation of tranexamic acid and impurities was performed using the Thermo Scientific Hypersil GOLD HPLC column according to the method described in the BP.