Sitagliptin Impurity 25 CAS CATO-C4X-114425

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-114425
Molecular FormulaC16H16F6N5O4P
Molecular Weight487.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 25 CAS CATO-C4X-114425 chemical structure

Description

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.

CATO supplies Sitagliptin Impurity 25 (CAS CATO-C4X-114425), a pharmacopoeial impurity reference standard (molecular formula C16H16F6N5O4P, MW 487.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H16F6N5O4P, Sitagliptin Impurity 25 contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 487.29 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC16H16F6N5O4P
Molecular Weight487.29 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)8.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms5

Related Sitagliptin Standards

Recommended Standards

Why CATO?