Miglitol Impurity 12 CAS 305379-00-4

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Miglitol Impurity 12.

As a process- or degradation-related impurity, Miglitol Impurity 12 (CAS 305379-00-4, C10H21NO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Miglitol Impurity 12 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 219.28 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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), Miglitol Impurity 12 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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