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    14622-47-0

    Catalog No. EBD3326516

    CAS 14622-47-0

    Name Pregna-1,4-diene-3,20-dione, 9,11-epoxy-17,21-dihydroxy-16-methyl-, (11α,16α)-

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    Basic Information

    Synonyms: Pregna-1,4-diene-3,20-dione,9,11-epoxy-17,21-dihydroxy-16-methyl-,(11α,16α)- 16β-METHYLEPOXIDE(DB-11),17α,21-DIHYDROXY-9β,11β,EPOXY-16β-METHYLPREGN-1,4-DIENE-3,20-DIONE 16BETA-METHYLEPOXIDE(DB-11):17ALPHA,21-DIHYDROXY-9BETA,11BETA,EPOXY-16BETA-METHYLPREGN-1,4-DIENE-3,20-DIONE

    Molecular Formula: C22H28O5

    Molecular Weight: 372.45

    Categories: Medicinal Chemistry > Drug Impurities and Reference Standards > Impurity Standards Medicinal Chemistry > APIs and Their Salts > Immuno-modulators and Anti-inflammatory Drugs

    Product Description:
    This compound, with the systematic name (11α,16α)-9,11-epoxy-17,21-dihydroxy-16-methylpregna-1,4-diene-3,20-dione, is a known impurity and degradation product of the potent synthetic glucocorticoid Dexamethasone. It is structurally characterized as a pregnane derivative featuring a 1,4-diene-3-one system, an 11α,16α-methyl configuration, and a 9,11-epoxy bridge, which differentiates it from the parent API. Its primary significance lies in the pharmaceutical quality control and analytical chemistry fields. It is used as a reference standard (impurity standard) in high-performance liquid chromatography (HPLC) and other analytical methods for the identification, quantification, and monitoring of this specific impurity during the manufacturing process and stability studies of Dexamethasone drug substances and finished products. Controlling such impurities is critical to ensuring the safety, efficacy, and regulatory compliance of the corticosteroid medication. As a defined chemical entity related to a major therapeutic agent, it is not a common synthetic building block but a specialized analytical tool. Handling requires standard laboratory precautions for fine chemicals, and it should be stored under appropriate conditions to maintain its stability as a reference material.
    Physical Properties
    mg g kg ml l t