Tretinoin Impurity 10 CAS CATO-C4X-196910

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Tretinoin Impurity 10.

CATO supplies Tretinoin Impurity 10 (CAS CATO-C4X-196910), a pharmacopoeial impurity reference standard (molecular formula C23H32O2, MW 340.50 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, a hydroxyl group, an ether linkage, Tretinoin Impurity 10 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 340.50 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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