rac-Domperidone EP Impurity C (Domperidone N-Oxide) CAS 118435-03-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.118435-03-3
Molecular FormulaC22H24ClN5O3
Molecular Weight441.91 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

rac-Domperidone EP Impurity C (Domperidone N-Oxide) CAS 118435-03-3 chemical structure

Description

The occurrence of rac-Domperidone EP Impurity C (Domperidone N-Oxide) is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, rac-Domperidone EP Impurity C (Domperidone N-Oxide) (CAS 118435-03-3, C22H24ClN5O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of rac-Domperidone EP Impurity C (Domperidone N-Oxide) (C22H24ClN5O3) is characterized by a steroid 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. 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 rac-Domperidone EP Impurity C (Domperidone N-Oxide) 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 FormulaC22H24ClN5O3
Molecular Weight441.91 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore in a cool place (≤25°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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentCl-containing
Nitrogen Atoms5

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