Galantamine EP Impurity E (N-Desmethyl Galanthamine) CAS 41303-74-6

Description

The occurrence of Galantamine EP Impurity E (N-Desmethyl Galanthamine) is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Galantamine EP Impurity E (N-Desmethyl Galanthamine) (CAS 41303-74-6) is a certified pharmaceutical impurity reference standard with the molecular formula C16H19NO3 and a molecular weight of 273.33 g/mol.

Structurally, Galantamine EP Impurity E (N-Desmethyl Galanthamine) (C16H19NO3) contains a nitrogen-containing heterocyclic scaffold, 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 273.33 g/mol, it falls into the medium-molecular-weight range. 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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