Flucloxacillin impurity 16 CAS CATO-C4X-164716

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Flucloxacillin impurity 16.

CATO supplies Flucloxacillin impurity 16 (CAS CATO-C4X-164716), a pharmacopoeial impurity reference standard (molecular formula C38H32Cl2F2N6O9S2, MW 889.73 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Flucloxacillin impurity 16 (C38H32Cl2F2N6O9S2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Flucloxacillin impurity 16 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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