Dabigatran Impurity 95 CAS 3839-35-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dabigatran Impurity 95.

As a process- or degradation-related impurity, Dabigatran Impurity 95 (CAS 3839-35-8, C13H20O3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Dabigatran Impurity 95 (C13H20O3S) is characterized by a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

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