Neratinib Impurity 12 CAS 1144516-18-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1144516-18-6
Molecular FormulaC31H32ClN6O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Neratinib Impurity 12 CAS 1144516-18-6 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 698.99 g/mol gives Neratinib Impurity 12 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Neratinib Impurity 12 (CAS 1144516-18-6, C31H32ClN6O3I) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Neratinib Impurity 12 (C31H32ClN6O3I) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine/iodine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Neratinib Impurity 12 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 FormulaC31H32ClN6O3 I
Molecular Weight698.99 g/mol
Purity>95%
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)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Halogen ContentCl/I-containing
Nitrogen Atoms6

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