Sitagliptin Impurity 26 CAS 1402569-71-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1402569-71-4
Molecular FormulaC16H20F3NO4
Molecular Weight347.33 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 26 CAS 1402569-71-4 chemical structure

Description

CATO supplies Sitagliptin Impurity 26 (CAS 1402569-71-4), a pharmacopoeial impurity reference standard (molecular formula C16H20F3NO4, MW 347.33 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H20F3NO4, Sitagliptin Impurity 26 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 347.33 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 26 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 FormulaC16H20F3NO4
Molecular Weight347.33 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentF-containing
Nitrogen Atoms1

Related Sitagliptin Standards

Recommended Standards

Why CATO?