Fudosteine Impurity 12 CAS CATO-C4X-144712

Description

The occurrence of Fudosteine Impurity 12 is closely related to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Fudosteine Impurity 12 (CAS CATO-C4X-144712, C8H17NO3SHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Fudosteine Impurity 12 (C8H17NO3SHCl) contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 0.0, corresponding to approximately 0 ring(s) or double-bond equivalent(s). With a molecular weight of 243.75 g/mol, it falls into the medium-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Fudosteine Impurity 12 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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