Tapentadol Impurity 16 CAS CATO-C4X-209916

Purity ＞95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-209916
Molecular FormulaC13H21NO
Molecular Weight207.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tapentadol Impurity 16 CAS CATO-C4X-209916 chemical structure

Description

The molecular framework of Tapentadol Impurity 16 (C13H21NO) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

As a process- or degradation-related impurity, Tapentadol Impurity 16 (CAS CATO-C4X-209916, C13H21NO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 Tapentadol Impurity 16 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

Molecular FormulaC13H21NO
Molecular Weight207.31 g/mol
Purity＞95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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