Pitavastatin Impurity 56 CAS CATO-C4X-103756

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-103756
Molecular FormulaC37H31NP
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 56 CAS CATO-C4X-103756 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.

CATO supplies Pitavastatin Impurity 56 (CAS CATO-C4X-103756), a pharmacopoeial impurity reference standard (molecular formula C37H31NPBr, MW 600.54 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pitavastatin Impurity 56 (C37H31NPBr) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, organophosphorus functionality, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 22.5, corresponding to approximately 22 ring(s) or double-bond equivalent(s). With a molecular weight of 600.54 g/mol, it falls into the high-molecular-weight range. 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 FormulaC37H31NP Br
Molecular Weight600.54 g/mol
Purity>95%
StorageStore at room temperature, protect from light
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)22.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms1

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