Tucatinib Impurity 36 CAS CATO-C4X-260536

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Tucatinib Impurity 36.

CATO supplies Tucatinib Impurity 36 (CAS CATO-C4X-260536), a pharmacopoeial impurity reference standard (molecular formula C20H22N8, MW 374.44 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Tucatinib Impurity 36 (C20H22N8) contains a nitrogen-containing heterocyclic scaffold, a nitrile group. The molecule exhibits a degree of unsaturation (DBE) of 14.0, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 374.44 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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