Pitavastatin Impurity 44 CAS CATO-C4X-103744

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-103744
Molecular FormulaC25H23FNO5
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 44 CAS CATO-C4X-103744 chemical structure

Description

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

CATO supplies Pitavastatin Impurity 44 (CAS CATO-C4X-103744), a pharmacopoeial impurity reference standard (molecular formula C25H23FNO5Ca, MW 476.54 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Pitavastatin Impurity 44 (C25H23FNO5Ca) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 14.5, corresponding to approximately 14 ring(s) or double-bond equivalent(s). With a molecular weight of 476.54 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC25H23FNO5 Ca
Molecular Weight476.54 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
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)14.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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