Sitagliptin Impurity 86 CAS 1246961-45-4

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1246961-45-4
Molecular FormulaC19H26F3NO4
Molecular Weight389.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 86 CAS 1246961-45-4 chemical structure

Description

CATO manufactures Sitagliptin Impurity 86 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.

CATO supplies Sitagliptin Impurity 86 (CAS 1246961-45-4), a pharmacopoeial impurity reference standard (molecular formula C19H26F3NO4, MW 389.41 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C19H26F3NO4, Sitagliptin Impurity 86 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 389.41 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

Physical & Chemical Properties

Molecular FormulaC19H26F3NO4
Molecular Weight389.41 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Halogen ContentF-containing
Nitrogen Atoms1

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