Sitagliptin Impurity 62 CAS 723286-98-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.723286-98-4
Molecular FormulaC4H2ClF3N2O
Molecular Weight186.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 62 CAS 723286-98-4 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 186.52 g/mol gives Sitagliptin Impurity 62 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Sitagliptin Impurity 62 (CAS 723286-98-4, C4H2ClF3N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Sitagliptin Impurity 62 (C4H2ClF3N2O) contains an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

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 FormulaC4H2ClF3N2O
Molecular Weight186.52 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1986
Halogen ContentF/Cl-containing
Nitrogen Atoms2

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