Ceritinib Impurity 76 CAS CATO-C4X-104876

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-104876
Molecular FormulaC28H36ClN5O3S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ceritinib Impurity 76 CAS CATO-C4X-104876 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 672.16 g/mol gives Ceritinib Impurity 76 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Ceritinib Impurity 76 (CAS CATO-C4X-104876), a pharmacopoeial impurity reference standard (molecular formula C28H36ClN5O3SC2HF3O2, MW 672.16 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ceritinib Impurity 76 (C28H36ClN5O3SC2HF3O2) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 672.16 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.

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

Molecular FormulaC28H36ClN5O3S 2*C2HF3O2
Molecular Weight672.16 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms5
Sulfur Atoms1

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