Pregabalin Impurity N48 CAS 35158-25-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.35158-25-9
Molecular FormulaC10H18O
Molecular Weight154.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity N48 CAS 35158-25-9 chemical structure

Description

CATO manufactures Pregabalin Impurity N48 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.

As a process- or degradation-related impurity, Pregabalin Impurity N48 (CAS 35158-25-9, C10H18O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Pregabalin Impurity N48 (C10H18O) is characterized by 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. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

Physical & Chemical Properties

Molecular FormulaC10H18O
Molecular Weight154.25 g/mol
Purity97%+
StorageStore at 2-8°C
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1967

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