Sitagliptin Impurity 127 CAS CATO-C4X-1144127

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1144127
Molecular FormulaC11H16O5
Molecular Weight228.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 127 CAS CATO-C4X-1144127 chemical structure

Description

Sitagliptin Impurity 127 (CAS CATO-C4X-1144127) is a certified pharmaceutical impurity reference standard with the molecular formula C11H16O5 and a molecular weight of 228.24 g/mol.

Sitagliptin Impurity 127 (C11H16O5) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

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 FormulaC11H16O5
Molecular Weight228.24 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>95%
StorageStore in a cool place (≤25°C), keep sealed and dry
Solubility (reference)Soluble in methanol, ethanol, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present

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