Lapatinib Impurity 25 CAS 231278-20-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.231278-20-9
Molecular FormulaC21H14ClFIN3O
Molecular Weight505.71 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lapatinib Impurity 25 CAS 231278-20-9 chemical structure

Description

As a process- or degradation-related impurity, Lapatinib Impurity 25 (CAS 231278-20-9, C21H14ClFIN3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C21H14ClFIN3O, Lapatinib Impurity 25 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine/iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 505.71 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Lapatinib Impurity 25 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 FormulaC21H14ClFIN3O
Molecular Weight505.71 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2023
Halogen ContentF/Cl/I-containing
Nitrogen Atoms3

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