Pitolisant impurity 16 CAS 31951-46-9

Description

The occurrence of Pitolisant impurity 16 is closely related to a nitrile group in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Pitolisant impurity 16 (CAS 31951-46-9), a pharmacopoeial impurity reference standard (molecular formula C13H26N2, MW 210.36 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Pitolisant impurity 16 (C13H26N2) is characterized by a nitrile group. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

As a certified reference material (CRM), Pitolisant impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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