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EP 8.0 monograph: impurity analysis of tranexamic acid using a C18 HPLC column
Description
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 ).Market: | Pharma |
Keywords: | HPLC, Hypersil GOLD, Tranexamic acid, UV detection, EP 8.0 monograph |
Matrix: | N/A |
Author: | Manish Singh |
Affiliation: | Thermo Fisher Scientific |
For Research Use Only. Not for use in diagnostic procedures.