Quinidine Impurity 3 CAS 485-65-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.485-65-4
Molecular FormulaC19H24N2O
Molecular Weight296.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Quinidine Impurity 3 CAS 485-65-4 chemical structure

Description

Quinidine Impurity 3 (C19H24N2O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a process- or degradation-related impurity, Quinidine Impurity 3 (CAS 485-65-4, C19H24N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC19H24N2O
Molecular Weight296.41 g/mol
AppearancePale yellow to yellow crystalline powder
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms2

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