Levothyroxine Impurity 57 CAS CATO-C4X-167857

Description

The occurrence of Levothyroxine Impurity 57 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Levothyroxine Impurity 57 (CAS CATO-C4X-167857, C21H17I4NO10) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Levothyroxine Impurity 57 (C21H17I4NO10) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 950.98 g/mol, it falls into the high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Levothyroxine Impurity 57 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.

Physical & Chemical Properties

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