Brigatinib Impurity 1 CAS CATO-C4X-26451

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-26451
Molecular FormulaC38H55ClN10O2
Molecular Weight719.36 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Brigatinib Impurity 1 CAS CATO-C4X-26451 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Brigatinib Impurity 1.

Brigatinib Impurity 1 (CAS CATO-C4X-26451) is a certified pharmaceutical impurity reference standard with the molecular formula C38H55ClN10O2 and a molecular weight of 719.36 g/mol.

Structurally, Brigatinib Impurity 1 (C38H55ClN10O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 16.0, corresponding to approximately 16 ring(s) or double-bond equivalent(s). With a molecular weight of 719.36 g/mol, it falls into the high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 Brigatinib Impurity 1 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

Molecular FormulaC38H55ClN10O2
Molecular Weight719.36 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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms10

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