Gadobutrol Impurity 146 CAS CATO-C4X-2120146

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Gadobutrol Impurity 146.

Gadobutrol Impurity 146 (CAS CATO-C4X-2120146) is a certified pharmaceutical impurity reference standard with the molecular formula C16H30N4O7H4N and a molecular weight of 408.48 g/mol.

Gadobutrol Impurity 146 (C16H30N4O7H4N) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Gadobutrol Impurity 146 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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