Epinastine Impurity 34 CAS 76838-40-9

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Epinastine Impurity 34.

CATO supplies Epinastine Impurity 34 (CAS 76838-40-9), a pharmacopoeial impurity reference standard (molecular formula C21H18N2OS, MW 346.45 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Epinastine Impurity 34 (C21H18N2OS) contains a steroid core, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 14.0, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 346.45 g/mol, it falls into the moderately-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).

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), Epinastine Impurity 34 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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