Mirogabalin Impurity 109 CAS 1644251-48-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Mirogabalin Impurity 109.

As a process- or degradation-related impurity, Mirogabalin Impurity 109 (CAS 1644251-48-8, C13H18O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C13H18O2, Mirogabalin Impurity 109 contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 206.28 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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), Mirogabalin Impurity 109 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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