Pitavastatin calcium Impurity 100 CAS CATO-C4X-1037100

Purity 80%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1037100
Molecular Formula4*C25H23FNO4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin calcium Impurity 100 CAS CATO-C4X-1037100 chemical structure

Description

CATO manufactures Pitavastatin calcium Impurity 100 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.

As a process- or degradation-related impurity, Pitavastatin calcium Impurity 100 (CAS CATO-C4X-1037100, C25H23FNO4Ca) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Pitavastatin calcium Impurity 100 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 460.54 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

Physical & Chemical Properties

Molecular Formula4*C25H23FNO4 2*Ca
Molecular Weight460.54 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity80%
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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