Safinamide Impurity 57 CAS CATO-C4X-159057

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-159057
Molecular FormulaC28H25F2NO2
Molecular Weight445.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Safinamide Impurity 57 CAS CATO-C4X-159057 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 Safinamide Impurity 57.

Safinamide Impurity 57 (CAS CATO-C4X-159057) is a certified pharmaceutical impurity reference standard with the molecular formula C28H25F2NO2 and a molecular weight of 445.50 g/mol.

Structurally, Safinamide Impurity 57 (C28H25F2NO2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 16.0, corresponding to approximately 16 ring(s) or double-bond equivalent(s). With a molecular weight of 445.50 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Safinamide Impurity 57 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 FormulaC28H25F2NO2
Molecular Weight445.50 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms1

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