Amlodipine Impurity 103 CAS 53901-54-5

Description

The occurrence of Amlodipine Impurity 103 is closely related to a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Amlodipine Impurity 103 (CAS 53901-54-5, C9H12O5S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C9H12O5S, Amlodipine Impurity 103 contains a sulfone group, 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 232.25 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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