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    1250-97-1

    Catalog No. EBD2335399

    CAS 1250-97-1

    Name [2-[(8S,9S,10R,11R,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]acetate

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    Basic Information

    Synonyms: [2-[(8S,9S,10R,11R,13S,14S,17R)-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]acetate 11α,17,21-trihydroxypregn-4-ene-3,20-dione21-acetate 11-epihydrocortisoneacetate (11alpha)-11,17-dihydroxy-3,20-dioxopregn-4-en-21-ylacetate

    Molecular Formula: C23H31O6-

    Molecular Weight: 403.49

    Categories: Medicinal Chemistry > Drug Impurities and Reference Standards > Impurity Standards Medicinal Chemistry > APIs and Their Salts > Endocrine & Metabolic Drugs

    Product Description:
    This compound, known as Hydrocortisone Acetate EP Impurity F, is a specific impurity and degradation product of the active pharmaceutical ingredient (API) hydrocortisone acetate. Its chemical structure is an acetate ester derivative of hydrocortisone, featuring the characteristic steroidal cyclopenta[a]phenanthrene core with hydroxyl and ketone functional groups at specific positions (C11, C17, C3). It is identified and controlled as a specified impurity in the European Pharmacopoeia (EP) monograph for hydrocortisone acetate. As an EP impurity standard, its primary application is in the pharmaceutical quality control and analytical development processes. It is used as a certified reference material (CRM) for the identification, quantification, and validation of analytical methods (e.g., HPLC, UPLC) to ensure the purity, safety, and efficacy of hydrocortisone acetate drug products. Its presence and level are monitored to comply with stringent regulatory requirements. The compound is crucial for assessing the stability and degradation pathways of hydrocortisone acetate formulations. Handling requires standard laboratory precautions for fine chemicals, and it should be stored under recommended conditions to maintain its stability as a reference standard.
    Physical Properties

    Boiling Point: 576.6°Cat760mmHg

    Flash Point: 196.2°C

    Density: 1.26g/cm3

    mg g kg ml l t