Tegoprazan Impurity 15 CAS CATO-C4X-229715

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-229715
Molecular FormulaC27H25F2N3O3
Molecular Weight477.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tegoprazan Impurity 15 CAS CATO-C4X-229715 chemical structure

Description

As a process- or degradation-related impurity, Tegoprazan Impurity 15 (CAS CATO-C4X-229715, C27H25F2N3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Tegoprazan Impurity 15 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 477.50 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 FormulaC27H25F2N3O3
Molecular Weight477.50 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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