Pitavastatin Impurity 97 CAS 1356998-79-2

Description

The occurrence of Pitavastatin Impurity 97 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Pitavastatin Impurity 97 (CAS 1356998-79-2), a pharmacopoeial impurity reference standard (molecular formula C19H16FN, MW 277.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Pitavastatin Impurity 97 (C19H16FN) 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. 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.

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

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