Tadalafil Impurity 57 CAS CATO-C4X-108757

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108757
Molecular FormulaC22H20N2O6
Molecular Weight408.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tadalafil Impurity 57 CAS CATO-C4X-108757 chemical structure

Description

The occurrence of Tadalafil Impurity 57 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Tadalafil Impurity 57 (CAS CATO-C4X-108757), a pharmacopoeial impurity reference standard (molecular formula C22H20N2O6, MW 408.40 g/mol) used for the identification and quantification of trace impurities in APIs.

Tadalafil Impurity 57 (C22H20N2O6) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Tadalafil 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 FormulaC22H20N2O6
Molecular Weight408.40 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>90%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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