Linagliptin Impurity N13 CAS 2138392-83-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2138392-83-1
Molecular FormulaC26H21BrN8O2
Molecular Weight557.41 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Linagliptin Impurity N13 CAS 2138392-83-1 chemical structure

Description

As a certified reference material (CRM), Linagliptin Impurity N13 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.

CATO supplies Linagliptin Impurity N13 (CAS 2138392-83-1), a pharmacopoeial impurity reference standard (molecular formula C26H21BrN8O2, MW 557.41 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Linagliptin Impurity N13 (C26H21BrN8O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC26H21BrN8O2
Molecular Weight557.41 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)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Halogen ContentBr-containing
Nitrogen Atoms8

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