Ropivacaine Impurity 16 CAS 1391053-59-0

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ropivacaine Impurity 16.

CATO supplies Ropivacaine Impurity 16 (CAS 1391053-59-0), a pharmacopoeial impurity reference standard (molecular formula C17H26N2O2, MW 290.40 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ropivacaine Impurity 16 (C17H26N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 290.40 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

As a certified reference material (CRM), Ropivacaine 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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