Quetiapine EP Impurity S HCl CAS 329216-63-9 (free base)

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.329216-63-9 (free base)
Molecular FormulaC21H25N3O3S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Quetiapine EP Impurity S HCl CAS 329216-63-9 (free base) chemical structure

Description

Quetiapine EP Impurity S HCl (CAS 329216-63-9 (free base)) is a certified pharmaceutical impurity reference standard with the molecular formula C21H25N3O3SHCl and a molecular weight of 435.97 g/mol.

Based on its molecular formula C21H25N3O3SHCl, Quetiapine EP Impurity S HCl contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 435.97 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

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 FormulaC21H25N3O3S HCl
Molecular Weight435.97 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3
Sulfur Atoms1

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