Osimertinib Impurity 54 CAS 27065-95-8

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.27065-95-8
Molecular FormulaC28H25N3
Molecular Weight403.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Osimertinib Impurity 54 CAS 27065-95-8 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 Osimertinib Impurity 54.

CATO supplies Osimertinib Impurity 54 (CAS 27065-95-8), a pharmacopoeial impurity reference standard (molecular formula C28H25N3, MW 403.52 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Osimertinib Impurity 54 (C28H25N3) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Osimertinib Impurity 54 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 FormulaC28H25N3
Molecular Weight403.52 g/mol
AppearancePale yellow to yellow crystalline powder
Purity≥95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1964
Nitrogen Atoms3

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