Tucatinib Impurity 61 (E-Isomer) CAS CATO-C4X-260561

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-260561
Molecular FormulaC28H32N8O2S
Molecular Weight544.67 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tucatinib Impurity 61 (E-Isomer) CAS CATO-C4X-260561 chemical structure

Description

As a process- or degradation-related impurity, Tucatinib Impurity 61 (E-Isomer) (CAS CATO-C4X-260561, C28H32N8O2S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Tucatinib Impurity 61 (E-Isomer) (C28H32N8O2S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 17.0, corresponding to approximately 17 ring(s) or double-bond equivalent(s). With a molecular weight of 544.67 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).

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), Tucatinib Impurity 61 (E-Isomer) 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

Molecular FormulaC28H32N8O2S
Molecular Weight544.67 g/mol
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms8
Sulfur Atoms1

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