Lotilaner Impurity 1 CAS 1369853-98-4

Description

The occurrence of Lotilaner Impurity 1 is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Lotilaner Impurity 1 (CAS 1369853-98-4), a pharmacopoeial impurity reference standard (molecular formula C20H14Cl3F6N3O3S, MW 596.76 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Lotilaner Impurity 1 (C20H14Cl3F6N3O3S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 596.76 g/mol, it falls into the moderately-high-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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