Gemigliptin impurity 1 CAS CATO-C4X-33061

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-33061
Molecular FormulaC18H17F8N5O
Molecular Weight471.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gemigliptin impurity 1 CAS CATO-C4X-33061 chemical structure

Description

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 process- or degradation-related impurity, Gemigliptin impurity 1 (CAS CATO-C4X-33061, C18H17F8N5O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Gemigliptin impurity 1 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 471.35 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

CATO manufactures Gemigliptin impurity 1 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 FormulaC18H17F8N5O
Molecular Weight471.35 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms5

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