Pitavastatin Impurity 21 CAS 154057-56-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.154057-56-4
Molecular FormulaC19H15BrFN
Molecular Weight356.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 21 CAS 154057-56-4 chemical structure

Description

CATO supplies Pitavastatin Impurity 21 (CAS 154057-56-4), a pharmacopoeial impurity reference standard (molecular formula C19H15BrFN, MW 356.23 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/bromine substitution, Pitavastatin Impurity 21 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 356.23 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

As a certified reference material (CRM), Pitavastatin Impurity 21 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC19H15BrFN
Molecular Weight356.23 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2001
Halogen ContentF/Br-containing
Nitrogen Atoms1

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