Empagliflozin Impurity 271 CAS CATO-C4X-1065271

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Empagliflozin Impurity 271.

As a process- or degradation-related impurity, Empagliflozin Impurity 271 (CAS CATO-C4X-1065271, C40H44Cl2O10) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Empagliflozin Impurity 271 (C40H44Cl2O10) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 18.0, corresponding to approximately 18 ring(s) or double-bond equivalent(s). With a molecular weight of 755.68 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Empagliflozin Impurity 271 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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