Paroxetine Impurity 67 HCl (Mixture of Diastereomers) CAS CATO-C4X-103567

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-103567
Molecular FormulaC12H16FNO
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Paroxetine Impurity 67 HCl (Mixture of Diastereomers) CAS CATO-C4X-103567 chemical structure

Description

The occurrence of Paroxetine Impurity 67 HCl (Mixture of Diastereomers) is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Paroxetine Impurity 67 HCl (Mixture of Diastereomers) (CAS CATO-C4X-103567, C12H16FNOHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Paroxetine Impurity 67 HCl (Mixture of Diastereomers) (C12H16FNOHCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. 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 aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

As a certified reference material (CRM), Paroxetine Impurity 67 HCl (Mixture of Diastereomers) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC12H16FNO HCl
Molecular Weight245.72 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms1

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