Gefitinib Impurity 34 CAS 194423-17-1

Description

The occurrence of Gefitinib Impurity 34 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Gefitinib Impurity 34 (CAS 194423-17-1) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12N4 and a molecular weight of 188.23 g/mol.

The molecular framework of Gefitinib Impurity 34 (C10H12N4) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group. 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Gefitinib Impurity 34 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

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