Ambroxol Sorbide Impurity 3(Ambroxol Impurity 79) CAS CATO-C4X-108579

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108579
Molecular FormulaC19H26Br2N2O6
Molecular Weight538.23 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Sorbide Impurity 3(Ambroxol Impurity 79) CAS CATO-C4X-108579 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 538.23 g/mol gives Ambroxol Sorbide Impurity 3(Ambroxol Impurity 79) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Ambroxol Sorbide Impurity 3(Ambroxol Impurity 79) (CAS CATO-C4X-108579, C19H26Br2N2O6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Ambroxol Sorbide Impurity 3(Ambroxol Impurity 79) (C19H26Br2N2O6) is characterized by a flavonoid 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. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

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 FormulaC19H26Br2N2O6
Molecular Weight538.23 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)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentBr-containing
Nitrogen Atoms2

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