Lapatinib Impurity 8 CAS 202198-16-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.202198-16-1
Molecular FormulaC21H16IN3O
Molecular Weight453.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lapatinib Impurity 8 CAS 202198-16-1 chemical structure

Description

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.

Lapatinib Impurity 8 (CAS 202198-16-1) is a certified pharmaceutical impurity reference standard with the molecular formula C21H16IN3O and a molecular weight of 453.28 g/mol.

The molecular framework of Lapatinib Impurity 8 (C21H16IN3O) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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).

As a certified reference material (CRM), Lapatinib Impurity 8 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 FormulaC21H16IN3O
Molecular Weight453.28 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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.)2014
Halogen ContentI-containing
Nitrogen Atoms3

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