Entecavir Impurity 86 CAS CATO-C4X-107786

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Entecavir Impurity 86.

CATO supplies Entecavir Impurity 86 (CAS CATO-C4X-107786), a pharmacopoeial impurity reference standard (molecular formula C52H47N5O3, MW 789.96 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Entecavir Impurity 86 (C52H47N5O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 32.0, corresponding to approximately 32 ring(s) or double-bond equivalent(s). With a molecular weight of 789.96 g/mol, it falls into the high-molecular-weight range. 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.

CATO manufactures Entecavir Impurity 86 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