Amisulpride EP Impurity D CAS 71676-00-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.71676-00-1
Molecular FormulaC16H25N3O4S
Molecular Weight355.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amisulpride EP Impurity D CAS 71676-00-1 chemical structure

Description

As a process- or degradation-related impurity, Amisulpride EP Impurity D (CAS 71676-00-1, C16H25N3O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Amisulpride EP Impurity D is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 355.45 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), Amisulpride 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 FormulaC16H25N3O4S
Molecular Weight355.45 g/mol
Purity>95%
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
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1977
Nitrogen Atoms3
Sulfur Atoms1

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