Pitavastatin Impurity 9(S,S) CAS CATO-C4X-10379

Description

The occurrence of Pitavastatin Impurity 9(S,S) is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Pitavastatin Impurity 9(S,S) (CAS CATO-C4X-10379, C32H36FNO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Pitavastatin Impurity 9(S,S) (C32H36FNO4) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. Halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; 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).

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.

CATO manufactures Pitavastatin Impurity 9(S,S) under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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