Posaconazole Impurity N1 CAS 2170933-06-7

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Posaconazole Impurity N1.

Posaconazole Impurity N1 (CAS 2170933-06-7) is a certified pharmaceutical impurity reference standard with the molecular formula C16H19F2IO3 and a molecular weight of 424.22 g/mol.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine/iodine substitution, an aromatic ring system, Posaconazole Impurity N1 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 424.22 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Posaconazole Impurity N1 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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