Nitrendipine Impurity 15 CAS CATO-C4X-183415

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Nitrendipine Impurity 15.

CATO supplies Nitrendipine Impurity 15 (CAS CATO-C4X-183415), a pharmacopoeial impurity reference standard (molecular formula C18H21NO4, MW 315.36 g/mol) used for the identification and quantification of trace impurities in APIs.

Nitrendipine Impurity 15 (C18H21NO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Nitrendipine Impurity 15 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
• 130,000+ catalog items in stock, COA supplied with every batch
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• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com