Sitagliptin Impurity 39 CAS CATO-C4X-1144139

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1144139
Molecular FormulaC10H10F6N6O2
Molecular Weight360.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 39 CAS CATO-C4X-1144139 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 360.22 g/mol gives Sitagliptin Impurity 39 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Sitagliptin Impurity 39 (CAS CATO-C4X-1144139), a pharmacopoeial impurity reference standard (molecular formula C10H10F6N6O2, MW 360.22 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Sitagliptin Impurity 39 (C10H10F6N6O2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 39 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 FormulaC10H10F6N6O2
Molecular Weight360.22 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms6

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