Ambroxol Maillard Lactose Impurity 8(Ambroxol Impurity 77) CAS CATO-C4X-108577

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108577
Molecular FormulaC18H26Br2N2O5
Molecular Weight510.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Maillard Lactose Impurity 8(Ambroxol Impurity 77) CAS CATO-C4X-108577 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 8(Ambroxol Impurity 77) (CAS CATO-C4X-108577), a pharmacopoeial impurity reference standard (molecular formula C18H26Br2N2O5, MW 510.22 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C18H26Br2N2O5, Ambroxol Maillard Lactose Impurity 8(Ambroxol Impurity 77) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 510.22 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

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 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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