Osimertinib Impurity 44 CAS CATO-C4X-204544

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-204544
Molecular FormulaC7H7FN2O3
Molecular Weight186.14 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Osimertinib Impurity 44 CAS CATO-C4X-204544 chemical structure

Description

The occurrence of Osimertinib Impurity 44 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Osimertinib Impurity 44 (CAS CATO-C4X-204544) is a certified pharmaceutical impurity reference standard with the molecular formula C7H7FN2O3 and a molecular weight of 186.14 g/mol.

Osimertinib Impurity 44 (C7H7FN2O3) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. It is notably hygroscopic, 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.

As a certified reference material (CRM), Osimertinib Impurity 44 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 FormulaC7H7FN2O3
Molecular Weight186.14 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity≥95%
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, ethanol, DMSO, water
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms2

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