Ambroxol Maillard Lactose Impurity 1(Ambroxol Impurity 70) CAS CATO-C4X-108570

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108570
Molecular FormulaC18H26Br2N2O5
Molecular Weight510.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Maillard Lactose Impurity 1(Ambroxol Impurity 70) CAS CATO-C4X-108570 chemical structure

Description

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.

CATO supplies Ambroxol Maillard Lactose Impurity 1(Ambroxol Impurity 70) (CAS CATO-C4X-108570), a pharmacopoeial impurity reference standard (molecular formula C18H26Br2N2O5, MW 510.22 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Ambroxol Maillard Lactose Impurity 1(Ambroxol Impurity 70) (C18H26Br2N2O5) 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.

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.

Physical & Chemical Properties

Molecular FormulaC18H26Br2N2O5
Molecular Weight510.22 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>90%
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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms2

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