Ambroxol Sorbide Impurity 2(Ambroxol Impurity 78) CAS CATO-C4X-108578

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-108578
Molecular FormulaC19H28Br2N2O6
Molecular Weight540.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ambroxol Sorbide Impurity 2(Ambroxol Impurity 78) CAS CATO-C4X-108578 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ambroxol Sorbide Impurity 2(Ambroxol Impurity 78).

CATO supplies Ambroxol Sorbide Impurity 2(Ambroxol Impurity 78) (CAS CATO-C4X-108578), a pharmacopoeial impurity reference standard (molecular formula C19H28Br2N2O6, MW 540.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ambroxol Sorbide Impurity 2(Ambroxol Impurity 78) (C19H28Br2N2O6) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 540.24 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

CATO manufactures Ambroxol Sorbide Impurity 2(Ambroxol Impurity 78) under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC19H28Br2N2O6
Molecular Weight540.24 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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