Trelagliptin Impurity 68 CAS CATO-C4X-104668

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-104668
Molecular FormulaC20H19F4N5O3
Molecular Weight453.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Trelagliptin Impurity 68 CAS CATO-C4X-104668 chemical structure

Description

As a certified reference material (CRM), Trelagliptin Impurity 68 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

CATO supplies Trelagliptin Impurity 68 (CAS CATO-C4X-104668), a pharmacopoeial impurity reference standard (molecular formula C20H19F4N5O3, MW 453.39 g/mol) used for the identification and quantification of trace impurities in APIs.

Trelagliptin Impurity 68 (C20H19F4N5O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; 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.

Physical & Chemical Properties

Molecular FormulaC20H19F4N5O3
Molecular Weight453.39 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms5

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