Trelagliptin Impurity 35 1/4Succinate CAS CATO-C4X-104635

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-104635
Molecular FormulaC18H20FN5O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Trelagliptin Impurity 35 1/4Succinate CAS CATO-C4X-104635 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Trelagliptin Impurity 35 1/4Succinate.

CATO supplies Trelagliptin Impurity 35 1/4Succinate (CAS CATO-C4X-104635), a pharmacopoeial impurity reference standard (molecular formula C18H20FN5O21/4(C4H6O4), MW 779.46 g/mol) used for the identification and quantification of trace impurities in APIs.

Trelagliptin Impurity 35 1/4Succinate (C18H20FN5O21/4(C4H6O4)) contains a flavonoid core, an amide 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. 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.

As a certified reference material (CRM), Trelagliptin Impurity 35 1/4Succinate 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.

Physical & Chemical Properties

Molecular FormulaC18H20FN5O2 1/4(C4H6O4)
Molecular Weight475.48 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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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