Atorvastatin Impurity N2 CAS 40281-50-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.40281-50-3
Molecular FormulaC14H11FO
Molecular Weight214.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Atorvastatin Impurity N2 CAS 40281-50-3 chemical structure

Description

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.

As a process- or degradation-related impurity, Atorvastatin Impurity N2 (CAS 40281-50-3, C14H11FO) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system, Atorvastatin Impurity N2 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 214.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

Physical & Chemical Properties

Molecular FormulaC14H11FO
Molecular Weight214.23 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1968
Halogen ContentF-containing

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