Pyridoxine Impurity 65 DiHCl CAS CATO-C4X-187765

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-187765
Molecular FormulaC16H20N2O5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pyridoxine Impurity 65 DiHCl CAS CATO-C4X-187765 chemical structure

Description

CATO manufactures Pyridoxine Impurity 65 DiHCl 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.

CATO supplies Pyridoxine Impurity 65 DiHCl (CAS CATO-C4X-187765), a pharmacopoeial impurity reference standard (molecular formula C16H20N2O5HCl, MW 356.80 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Pyridoxine Impurity 65 DiHCl (C16H20N2O5HCl) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, 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.

Physical & Chemical Properties

Molecular FormulaC16H20N2O5 2*HCl
Molecular Weight356.80 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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