Sitagliptin Impurity 55 CAS CATO-C4X-114455

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-114455
Molecular FormulaC29H33F6N3O5
Molecular Weight617.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 55 CAS CATO-C4X-114455 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 617.58 g/mol gives Sitagliptin Impurity 55 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Sitagliptin Impurity 55 (CAS CATO-C4X-114455) is a certified pharmaceutical impurity reference standard with the molecular formula C29H33F6N3O5 and a molecular weight of 617.58 g/mol.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Sitagliptin Impurity 55 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 617.58 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

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.

CATO manufactures Sitagliptin Impurity 55 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC29H33F6N3O5
Molecular Weight617.58 g/mol
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3

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