Apixaban Impurity 107 CAS 118241-48-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Apixaban Impurity 107.

As a process- or degradation-related impurity, Apixaban Impurity 107 (CAS 118241-48-8, C11H16O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C11H16O3, Apixaban Impurity 107 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 196.24 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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