Drotaverine Impurity 16 CAS 37491-68-2

Description

The occurrence of Drotaverine Impurity 16 is closely related to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Drotaverine Impurity 16 (CAS 37491-68-2, C7H9NO2) 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, Drotaverine Impurity 16 is typically off-white to pale yellow liquid. Its solid-state physicochemical attributes — including a molecular weight of 139.15 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), Drotaverine 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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