Pitavastatin Impurity 85 CAS CATO-C4X-103785

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-103785
Molecular FormulaC19H14FNO2
Molecular Weight307.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 85 CAS CATO-C4X-103785 chemical structure

Description

The occurrence of Pitavastatin Impurity 85 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Pitavastatin Impurity 85 (CAS CATO-C4X-103785), a pharmacopoeial impurity reference standard (molecular formula C19H14FNO2, MW 307.32 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C19H14FNO2, Pitavastatin Impurity 85 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 307.32 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 85 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

Molecular FormulaC19H14FNO2
Molecular Weight307.32 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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