Lansoprazole EP Impurity C/USP Impurity B CAS 103577-40-8

Description

CATO manufactures Lansoprazole EP Impurity C/USP Impurity B 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.

CATO supplies Lansoprazole EP Impurity C/USP Impurity B (CAS 103577-40-8), a pharmacopoeial impurity reference standard (molecular formula C16H14F3N3OS, MW 353.36 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Lansoprazole EP Impurity C/USP Impurity B (C16H14F3N3OS) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

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
• Worldwide shipping with full export documentation (HS code guidance available)
• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com