Sitagliptin impurity 146 CAS CATO-C4X-1144146

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1144146
Molecular FormulaC18H19F6N7O2
Molecular Weight479.38 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin impurity 146 CAS CATO-C4X-1144146 chemical structure

Description

CATO supplies Sitagliptin impurity 146 (CAS CATO-C4X-1144146), a pharmacopoeial impurity reference standard (molecular formula C18H19F6N7O2, MW 479.38 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H19F6N7O2, Sitagliptin impurity 146 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 479.38 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC18H19F6N7O2
Molecular Weight479.38 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms7

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