Quetiapine EP Impurity I Fumarate CAS CATO-C4X-124453

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-124453
Molecular FormulaC19H21N3OS
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Quetiapine EP Impurity I Fumarate CAS CATO-C4X-124453 chemical structure

Description

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.

Quetiapine EP Impurity I Fumarate (CAS CATO-C4X-124453) is a certified pharmaceutical impurity reference standard with the molecular formula C19H21N3OSC4H4O4 and a molecular weight of 455.53 g/mol.

Owing to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Quetiapine EP Impurity I Fumarate is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 455.53 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC19H21N3OS C4H4O4
Molecular Weight455.53 g/mol
Purity97%+
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
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms3
Sulfur Atoms1

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