Quetiapine EP Impurity P CAS 1011758-03-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1011758-03-4
Molecular FormulaC19H21N3S
Molecular Weight323.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Quetiapine EP Impurity P CAS 1011758-03-4 chemical structure

Description

Quetiapine EP Impurity P (C19H21N3S) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

As a process- or degradation-related impurity, Quetiapine EP Impurity P (CAS 1011758-03-4, C19H21N3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 FormulaC19H21N3S
Molecular Weight323.46 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Nitrogen Atoms3
Sulfur Atoms1

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