Ambroxol Maillard Lactose Impurity 2(Ambroxol Impurity 71) CAS CATO-C4X-108571

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108571
Molecular FormulaC18H26Br2N2O5
Molecular Weight510.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Maillard Lactose Impurity 2(Ambroxol Impurity 71) CAS CATO-C4X-108571 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.

As a process- or degradation-related impurity, Ambroxol Maillard Lactose Impurity 2(Ambroxol Impurity 71) (CAS CATO-C4X-108571, C18H26Br2N2O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ambroxol Maillard Lactose Impurity 2(Ambroxol Impurity 71) (C18H26Br2N2O5) 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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