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    15942-08-2

    Catalog No. EBD3332357

    CAS 15942-08-2

    Name trans-4-(6,8-dibromo-1,4-dihydro-3(2H)-quinazolinyl)-Cyclohexanol, hydrochloride (1:1)

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    Basic Information

    Molecular Formula: C14H19Br2ClN2O

    Molecular Weight: 426.57

    Categories: Medicinal Chemistry > Drug Impurities and Reference Standards > Impurity Standards Medicinal Chemistry > APIs and Their Salts > Respiratory Drugs

    Product Description:
    Ambroxol Hydrochloride Impurity B is a specified impurity and degradation product of the active pharmaceutical ingredient (API) Ambroxol Hydrochloride. It is chemically identified as 2-amino-3,5-dibromobenzyl alcohol. This compound is structurally related to the parent drug and is formed during the synthesis or storage of Ambroxol. As a pharmacopoeial impurity, it is critical for quality control in the pharmaceutical industry. It is used as a reference standard in analytical methods, such as high-performance liquid chromatography (HPLC), to monitor and control the purity of Ambroxol Hydrochloride drug substances and finished products. Ambroxol itself is a widely used mucolytic agent for treating respiratory diseases associated with viscid or excessive mucus. The availability and characterization of this impurity standard are essential for regulatory compliance (e.g., ICH guidelines) and ensuring the safety and efficacy of the final medicinal product. Its primary role is confined to analytical and quality assurance applications within pharmaceutical development and manufacturing.
    Physical Properties
    mg g kg ml l t