N-Nitroso Lorlatinib impurity 1 CAS CATO-C4X-30911

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-30911
Molecular FormulaC21H20FN7O4
Molecular Weight453.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

N-Nitroso Lorlatinib impurity 1 CAS CATO-C4X-30911 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 453.43 g/mol gives N-Nitroso Lorlatinib impurity 1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

N-Nitroso Lorlatinib impurity 1 (CAS CATO-C4X-30911) is a certified pharmaceutical impurity reference standard with the molecular formula C21H20FN7O4 and a molecular weight of 453.43 g/mol.

The molecular framework of N-Nitroso Lorlatinib impurity 1 (C21H20FN7O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), N-Nitroso Lorlatinib impurity 1 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 FormulaC21H20FN7O4
Molecular Weight453.43 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms7

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