rac-Nicotine EP Impurity E CAS 63551-14-4

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including rac-Nicotine EP Impurity E.

As a process- or degradation-related impurity, rac-Nicotine EP Impurity E (CAS 63551-14-4, C10H14N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, rac-Nicotine EP Impurity E is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 178.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), rac-Nicotine EP Impurity E 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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