Sitagliptin Impurity 65 CAS 1620129-74-9

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1620129-74-9
Molecular FormulaC15H18F3NO4
Molecular Weight333.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 65 CAS 1620129-74-9 chemical structure

Description

The occurrence of Sitagliptin Impurity 65 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Sitagliptin Impurity 65 (CAS 1620129-74-9) is a certified pharmaceutical impurity reference standard with the molecular formula C15H18F3NO4 and a molecular weight of 333.30 g/mol.

Based on its molecular formula C15H18F3NO4, Sitagliptin Impurity 65 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 333.30 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC15H18F3NO4
Molecular Weight333.30 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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.)1993
Halogen ContentF-containing
Nitrogen Atoms1

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