Atropine EP Impurity A CAS 500-55-0

Description

Compared with other compounds in its class, the molecular weight of 271.35 g/mol gives Atropine EP Impurity A distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Atropine EP Impurity A (CAS 500-55-0, C17H21NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Atropine EP Impurity A (C17H21NO2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 271.35 g/mol, it falls into the medium-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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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