Domperidone Impurity N8 CAS 58859-46-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.58859-46-4
Molecular FormulaC8H16N2O2
Molecular Weight172.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Domperidone Impurity N8 CAS 58859-46-4 chemical structure

Description

As a certified reference material (CRM), Domperidone Impurity N8 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.

As a process- or degradation-related impurity, Domperidone Impurity N8 (CAS 58859-46-4, C8H16N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, Domperidone Impurity N8 (C8H16N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 172.22 g/mol, it falls into the medium-molecular-weight range. 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.

Physical & Chemical Properties

Molecular FormulaC8H16N2O2
Molecular Weight172.22 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1973
Nitrogen Atoms2

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