Sitagliptin Impurity 109 CAS CATO-C4X-1144109

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1144109
Molecular FormulaC16H12F6N4O2
Molecular Weight406.28 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 109 CAS CATO-C4X-1144109 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 406.28 g/mol gives Sitagliptin Impurity 109 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Sitagliptin Impurity 109 (CAS CATO-C4X-1144109), a pharmacopoeial impurity reference standard (molecular formula C16H12F6N4O2, MW 406.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H12F6N4O2, Sitagliptin Impurity 109 contains a nitrogen-containing heterocyclic scaffold, 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 406.28 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).

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.

As a certified reference material (CRM), Sitagliptin Impurity 109 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC16H12F6N4O2
Molecular Weight406.28 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 Atoms4

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