Sitagliptin Tablets EP Impurity FP-A CAS 2088771-60-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2088771-60-0
Molecular FormulaC20H19F6N5O5
Molecular Weight523.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Tablets EP Impurity FP-A  CAS 2088771-60-0 chemical structure

Description

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.

Sitagliptin Tablets EP Impurity FP-A (CAS 2088771-60-0) is a certified pharmaceutical impurity reference standard with the molecular formula C20H19F6N5O5 and a molecular weight of 523.39 g/mol.

Structurally, Sitagliptin Tablets EP Impurity FP-A (C20H19F6N5O5) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 523.39 g/mol, it falls into the moderately-high-molecular-weight range. 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.

Physical & Chemical Properties

Molecular FormulaC20H19F6N5O5
Molecular Weight523.39 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Halogen ContentF-containing
Nitrogen Atoms5

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