Pitavastatin Impurity 54 CAS 1187966-95-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1187966-95-5
Molecular FormulaC20H14FN
Molecular Weight287.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 54 CAS 1187966-95-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 287.33 g/mol gives Pitavastatin Impurity 54 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Pitavastatin Impurity 54 (CAS 1187966-95-5), a pharmacopoeial impurity reference standard (molecular formula C20H14FN, MW 287.33 g/mol) used for the identification and quantification of trace impurities in APIs.

Pitavastatin Impurity 54 (C20H14FN) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC20H14FN
Molecular Weight287.33 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1989
Halogen ContentF-containing
Nitrogen Atoms1

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