Quetiapine Fumarate EP Impurity P CAS CATO-C4X-124462

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-124462
Molecular FormulaC19H21N3S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Quetiapine Fumarate EP Impurity P CAS CATO-C4X-124462 chemical structure

Description

Quetiapine Fumarate EP Impurity P (CAS CATO-C4X-124462) is a certified pharmaceutical impurity reference standard with the molecular formula C19H21N3SHCl and a molecular weight of 359.92 g/mol.

Structurally, Quetiapine Fumarate EP Impurity P (C19H21N3SHCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 10.0, corresponding to approximately 10 ring(s) or double-bond equivalent(s). With a molecular weight of 359.92 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Quetiapine Fumarate EP Impurity P 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 FormulaC19H21N3S HCl
Molecular Weight359.92 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3
Sulfur Atoms1

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