Tadalafil impurity 165 CAS 385769-80-2

Description

The occurrence of Tadalafil impurity 165 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Tadalafil impurity 165 (CAS 385769-80-2), a pharmacopoeial impurity reference standard (molecular formula C21H17N3O5, MW 391.38 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Tadalafil impurity 165 (C21H17N3O5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 15.0, corresponding to approximately 15 ring(s) or double-bond equivalent(s). With a molecular weight of 391.38 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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