Lurbinectedin Impurity 23 CAS 2248127-73-1

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Lurbinectedin Impurity 23.

Lurbinectedin Impurity 23 (CAS 2248127-73-1) is a certified pharmaceutical impurity reference standard with the molecular formula C42H47N5O10S and a molecular weight of 813.92 g/mol.

Structurally, Lurbinectedin Impurity 23 (C42H47N5O10S) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 22.0, corresponding to approximately 22 ring(s) or double-bond equivalent(s). With a molecular weight of 813.92 g/mol, it falls into the high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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), Lurbinectedin Impurity 23 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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