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    50910-53-7

    Catalog No. EBD3332356

    CAS 50910-53-7

    Name trans-4-[[(2-amino-3,5-dibromophenyl)methylene]amino]-Cyclohexanol

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    Basic Information

    Molecular Formula: C13H16Br2N2O

    Molecular Weight: 376.09

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

    Product Description:
    Ambroxol Hydrochloride Impurity C is a specified impurity 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 monitored during the manufacturing process and quality control of Ambroxol formulations. As a pharmacopoeial impurity, its primary application is in the pharmaceutical industry for analytical purposes. It serves as a reference standard (impurity standard) in high-performance liquid chromatography (HPLC) and other analytical methods to quantify, identify, and control the level of this specific impurity in Ambroxol Hydrochloride drug substances and finished products. This is critical for ensuring drug safety, efficacy, and compliance with regulatory guidelines such as those from the ICH. Ambroxol Hydrochloride itself is a widely used mucolytic agent for treating respiratory diseases associated with viscid or excessive mucus. Therefore, the control and analysis of its related impurities, including Impurity C, are integral parts of the quality assurance for this important respiratory system drug.
    Physical Properties
    mg g kg ml l t