Sitagliptin Impurity 22 CAS 486460-23-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.486460-23-5
Molecular FormulaC21H23F6N5O3
Molecular Weight507.43 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sitagliptin Impurity 22 CAS 486460-23-5 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.

CATO supplies Sitagliptin Impurity 22 (CAS 486460-23-5), a pharmacopoeial impurity reference standard (molecular formula C21H23F6N5O3, MW 507.43 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C21H23F6N5O3, Sitagliptin Impurity 22 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 507.43 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).

CATO manufactures Sitagliptin Impurity 22 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 FormulaC21H23F6N5O3
Molecular Weight507.43 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025
Halogen ContentF-containing
Nitrogen Atoms5

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