Mianserin EP Impurity A CAS 57321-32-1

Description

Compared with other compounds in its class, the molecular weight of 282.38 g/mol gives Mianserin EP Impurity A distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Mianserin EP Impurity A (CAS 57321-32-1) is a certified pharmaceutical impurity reference standard with the molecular formula C18H22N2O and a molecular weight of 282.38 g/mol.

Structurally, Mianserin EP Impurity A (C18H22N2O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 282.38 g/mol, it falls into the medium-molecular-weight range. 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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