Tranexamic Impurity 38 CAS CATO-C4X-177138

Description

Compared with other compounds in its class, the molecular weight of 211.09 g/mol gives Tranexamic Impurity 38 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Tranexamic Impurity 38 (CAS CATO-C4X-177138), a pharmacopoeial impurity reference standard (molecular formula C8H12Cl2O2, MW 211.09 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Tranexamic Impurity 38 (C8H12Cl2O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 211.09 g/mol, it falls into the medium-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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