Tadalafil Impurity 48 CAS CATO-C4X-108748

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108748
Molecular FormulaC23H21ClN2O5
Molecular Weight440.88 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tadalafil Impurity 48 CAS CATO-C4X-108748 chemical structure

Description

CATO manufactures Tadalafil Impurity 48 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

CATO supplies Tadalafil Impurity 48 (CAS CATO-C4X-108748), a pharmacopoeial impurity reference standard (molecular formula C23H21ClN2O5, MW 440.88 g/mol) used for the identification and quantification of trace impurities in APIs.

Tadalafil Impurity 48 (C23H21ClN2O5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. 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. 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.

Physical & Chemical Properties

Molecular FormulaC23H21ClN2O5
Molecular Weight440.88 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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