Pitavastatin Impurity 67 CAS 586966-55-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.586966-55-4
Molecular FormulaC29H32FNO4
Molecular Weight477.57 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pitavastatin Impurity 67 CAS 586966-55-4 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 67.

CATO supplies Pitavastatin Impurity 67 (CAS 586966-55-4), a pharmacopoeial impurity reference standard (molecular formula C29H32FNO4, MW 477.57 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C29H32FNO4, Pitavastatin Impurity 67 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 477.57 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 67 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 FormulaC29H32FNO4
Molecular Weight477.57 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)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1984
Halogen ContentF-containing
Nitrogen Atoms1

Related Pitavastatin Standards

Recommended Standards

Why CATO?