Micafungin Impurity 20 CAS 1392514-06-5

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Micafungin Impurity 20.

Micafungin Impurity 20 (CAS 1392514-06-5) is a certified pharmaceutical impurity reference standard with the molecular formula C56H70N9O22SNa and a molecular weight of 1276.27 g/mol.

Structurally, Micafungin Impurity 20 (C56H70N9O22SNa) 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 26.5, corresponding to approximately 26 ring(s) or double-bond equivalent(s). With a molecular weight of 1276.27 g/mol, it falls into the high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Micafungin Impurity 20 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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