Omarigliptin Impurity 17 CAS CATO-C4X-114717

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-114717
Molecular FormulaC17H20F2N4O3S
Molecular Weight398.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Omarigliptin Impurity 17 CAS CATO-C4X-114717 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 Omarigliptin Impurity 17.

As a process- or degradation-related impurity, Omarigliptin Impurity 17 (CAS CATO-C4X-114717, C17H20F2N4O3S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Omarigliptin Impurity 17 (C17H20F2N4O3S) is characterized by a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

As a certified reference material (CRM), Omarigliptin Impurity 17 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 FormulaC17H20F2N4O3S
Molecular Weight398.43 g/mol
Purity97%+
StorageStore at 2-8°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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms4
Sulfur Atoms1

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