Linagliptin impurity N2 CAS 1446263-39-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1446263-39-3
Molecular FormulaC25H29BrN8O2
Molecular Weight553.45 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Linagliptin impurity N2 CAS 1446263-39-3 chemical structure

Description

The occurrence of Linagliptin impurity N2 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Linagliptin impurity N2 (CAS 1446263-39-3, C25H29BrN8O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Linagliptin impurity N2 (C25H29BrN8O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC25H29BrN8O2
Molecular Weight553.45 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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1992
Halogen ContentBr-containing
Nitrogen Atoms8

Related Linagliptin Standards

Recommended Standards

Why CATO?