Tadalafil EP Impurity C CAS 171596-28-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.171596-28-4
Molecular FormulaC22H19N3O4
Molecular Weight389.40 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tadalafil EP Impurity C CAS 171596-28-4 chemical structure

Description

As a process- or degradation-related impurity, Tadalafil EP Impurity C (CAS 171596-28-4, C22H19N3O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Tadalafil EP Impurity C (C22H19N3O4) 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC22H19N3O4
Molecular Weight389.40 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2006
Nitrogen Atoms3

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