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.
Bivalirudin Impurity 13 (CAS CATO-C4X-144813) is a certified pharmaceutical impurity reference standard with the molecular formula N/A and a molecular weight of N/A g/mol.
Bivalirudin Impurity 13 is supplied as a fully characterized reference material; its structural identity, assigned purity, and stability data are documented in the batch-specific Certificate of Analysis (COA).
CATO manufactures Bivalirudin Impurity 13 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.