Tranexamic Acid EP Impurity A

Development of SPME method for concomitant sample preparation of rocuronium bromide and tranexamic acid in plasma
Krzysztof Gorynski, Barbara Bojko, Michael Kluger, Angela Jerath, Marcin Wąsowicz, Janusz Pawliszyn
Journal of Pharmaceutical and Biomedical Analysis Volume 92, 15 April 2014, Pages 183-192
 
Densitometric Determination of Tranexamic Acid in Tablets: Validation of the Method
Hosiana Berniati Tampubolon,Endang Sumarlik,Mochammad Yuwono &Gunawan Indrayanto
Journal of Liquid Chromatography & Related Technologies  Volume 28, 2005 - Issue 20 Pages 3243-3254
 
Unification of procedures for determining pharmaceutical substances bearing ionogenic acidic and basic groups, tranexamic acid, ampasse, and ethylmethylhydroxypyridine succinate by reversed-phase HPLC
G. M. Khomushku, Yu. S. Brezhneva, V. S. Puchnin, S. M. Moiseeva & N. B. Epshtein
Journal of Analytical Chemistry volume 69, pages194–199(2014)

Tranexamic Acid EP Impurity A is chemically (1r,4r,1′r,4′r)-4,4′-[azanediylbis(methylene)]di(cyclohexane-1-carboxylic acid) (as per EP) ; trans,trans-4,4'-[Iminobis(methylene)]dicyclohexanecarboxylic acid (as per USP). It is also known as Tranexamic Acid Dimer ; Tranexamic Acid USP Related Compound A ; Ditranexamic Acid Amine (USP). Tranexamic Acid EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Tranexamic Acid EP Impurity A can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Tranexamic Acid.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.