Dapagliflozin Impurity 89 CAS CATO-C4X-113889

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dapagliflozin Impurity 89.

Dapagliflozin Impurity 89 (CAS CATO-C4X-113889) is a certified pharmaceutical impurity reference standard with the molecular formula C15H14BrClO and a molecular weight of 325.63 g/mol.

Owing to a hydroxyl group, an ether linkage, chlorine/bromine substitution, a polycyclic aromatic system, Dapagliflozin Impurity 89 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 325.63 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 Dapagliflozin Impurity 89 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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