Galantamine EP Impurity D CAS 664995-65-7

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.664995-65-7
Molecular FormulaC17H19NO2
Molecular Weight269.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Galantamine EP Impurity D CAS 664995-65-7 chemical structure

Description

The occurrence of Galantamine EP Impurity D is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Galantamine EP Impurity D (CAS 664995-65-7, C17H19NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, Galantamine EP Impurity D is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 269.34 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Galantamine EP Impurity D 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 FormulaC17H19NO2
Molecular Weight269.34 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
StorageStore at 2-8°C, protect from light
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1985
Nitrogen Atoms1

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