Pitavastatin Impurity 101 CAS 254452-96-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.254452-96-5
Molecular Formula2*C25H23FNO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 101 CAS 254452-96-5 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Pitavastatin Impurity 101.

Pitavastatin Impurity 101 (CAS 254452-96-5) is a certified pharmaceutical impurity reference standard with the molecular formula C25H23FNO4Ca and a molecular weight of 460.54 g/mol.

Pitavastatin Impurity 101 (C25H23FNO4Ca) contains a flavonoid core, 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).

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 manufactures Pitavastatin Impurity 101 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 Formula2*C25H23FNO4 Ca
Molecular Weight460.54 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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
CAS Registry Year (est.)2025
Halogen ContentF-containing
Nitrogen Atoms1

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