Moxidectin EP Impurity D CAS CATO-C4X-22751

Description

The occurrence of Moxidectin EP Impurity D 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.

CATO supplies Moxidectin EP Impurity D (CAS CATO-C4X-22751), a pharmacopoeial impurity reference standard (molecular formula C37H53NO8, MW 639.82 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Moxidectin EP Impurity D (C37H53NO8) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 639.82 g/mol, it falls into the high-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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