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    Chemistry

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    Also known as: 514-36-3, Scherofluron, Cortineff, Fludrocortisone 21-acetate, Florinef acetate, Alflorone acetate
    Molecular Formula
    C23H31FO6
    Molecular Weight
    422.5  g/mol
    InChI Key
    SYWHXTATXSMDSB-GSLJADNHSA-N
    FDA UNII
    V47IF0PVH4
    Fludrocortisone Acetate
    Fludrocortisone Acetate is the acetate salt of a synthetic fluorinated corticosteroid with antiinflammatory and antiallergic activities. As a glucocorticoid-receptor agonist, fludrocortisone binds to cytoplasmic receptors, translocates to the nucleus, and subsequently initiates the transcription of glucocorticoid-responsive genes such as lipocortins to inhibit phospholipase A2 (PLA2). Inhibition of PLA2 activity prevents the release of arachidonic acid, a precursor of eicosanoids such as prostaglandins and leukotrienes; eicosanoids are important mediators in the pro-inflammatory response mechanism. As a mineralocorticoid-receptor agonist, this agent stimulates Na+ reabsorption and water retention and K+ and H+ secretion in the distal tubules and collecting ducts of the kidney.
    1 2D Structure

    Fludrocortisone Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-[(8S,9R,10S,11S,13S,14S,17R)-9-fluoro-11,17-dihydroxy-10,13-dimethyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] acetate
    2.1.2 InChI
    InChI=1S/C23H31FO6/c1-13(25)30-12-19(28)22(29)9-7-16-17-5-4-14-10-15(26)6-8-20(14,2)23(17,24)18(27)11-21(16,22)3/h10,16-18,27,29H,4-9,11-12H2,1-3H3/t16-,17-,18-,20-,21-,22-,23-/m0/s1
    2.1.3 InChI Key
    SYWHXTATXSMDSB-GSLJADNHSA-N
    2.1.4 Canonical SMILES
    CC(=O)OCC(=O)C1(CCC2C1(CC(C3(C2CCC4=CC(=O)CCC43C)F)O)C)O
    2.1.5 Isomeric SMILES
    CC(=O)OCC(=O)[C@]1(CC[C@@H]2[C@@]1(C[C@@H]([C@]3([C@H]2CCC4=CC(=O)CC[C@@]43C)F)O)C)O
    2.2 Other Identifiers
    2.2.1 UNII
    V47IF0PVH4
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 9 Alpha-fluorocortisol Acetate

    2. 9-fluoro-11beta,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate

    3. Cortineff

    4. Florinef

    5. Fludrocortisone 21-acetate

    6. Fluorocortisol Acetate

    2.3.2 Depositor-Supplied Synonyms

    1. 514-36-3

    2. Scherofluron

    3. Cortineff

    4. Fludrocortisone 21-acetate

    5. Florinef Acetate

    6. Alflorone Acetate

    7. Fluorocortisol Acetate

    8. Cortef-f

    9. F-cortef Acetate

    10. Fluorocortisone Acetate

    11. Fluohydrocortisone Acetate

    12. Fludrocortisoneacetate

    13. 9alpha-fluorohydrocortisone Acetate

    14. Nsc-15186

    15. U 4845

    16. 9alpha-fluorohydrocortisone 21-acetate

    17. V47if0pvh4

    18. 514-36-3 (acetate)

    19. Chebi:5102

    20. 2-((8s,9r,10s,11s,13s,14s,17r)-9-fluoro-11,17-dihydroxy-10,13-dimethyl-3-oxo-2,3,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl Acetate

    21. Pregn-4-ene-3,20-dione, 21-(acetyloxy)-9-fluoro-11,17-dihydroxy-,(11b)-

    22. [2-[(8s,9r,10s,11s,13s,14s,17r)-9-fluoro-11,17-dihydroxy-10,13-dimethyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Acetate

    23. (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl Acetate

    24. 9alpha-fluoro-11beta,17alpha,21-trihydroxy-pregn-4-en-3,20-dione 21-acetate

    25. Mls002638417

    26. Fludrocortisone (acetate)

    27. Mfcd00864160

    28. Unii-v47if0pvh4

    29. Fludrocortisone Acetate [jan]

    30. 9-fluoro-11-beta,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate

    31. Fludrocortisonacetat

    32. Cortisol, 9-fluoro-, 21-acetate

    33. Fludrocortisone Acetate [usp:jan]

    34. 9-alpha-fluorohydrocortisone Acetate

    35. Einecs 208-180-4

    36. Nsc 15186

    37. Fludrocortisoni Acetas

    38. Fludrocortisone-acetate

    39. 9-alpha-fluorohydrocortisone-21-acetate

    40. Brn 2067486

    41. Florinef Acetate (tn)

    42. 9a-fluorcortisol Acetate

    43. 9a-fluorocortisol Acetate

    44. Prestwick0_000281

    45. Prestwick1_000281

    46. Prestwick2_000281

    47. 9-fluoro-11beta,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate

    48. 9a-fludrocortisone Acetate

    49. Acetic Acid Fludrocortisone

    50. Schembl4737

    51. Corticosterone, 9-fluoro-17-hydroxy-, 21-acetate

    52. Spbio_002401

    53. 9.alpha.-fluorocortisol Acetate

    54. Chembl1201010

    55. Dtxsid2023062

    56. Fludrocortisone Acetate, >=98%

    57. Hy-b1203a

    58. Fluorhydrocortisone Acetate

    59. Hms1568j04

    60. Nsc15186

    61. Zinc3977990

    62. Fludrocortisone Acetate (jp17/usp)

    63. Lmst02030122

    64. S3659

    65. 9.alpha.-fluorohydrocortisone Acetate

    66. Akos015963145

    67. Ccg-268914

    68. Cs-4833

    69. Ds-3879

    70. Fludrocortisone Acetate [mart.]

    71. Fludrocortisone Acetate [vandf]

    72. Fludrocortisone Acetate [usp-rs]

    73. Fludrocortisone Acetate [who-dd]

    74. Fludrocortisone Acetate [who-ip]

    75. Pregn-4-ene-3,20-dione, 21-(acetyloxy)-9-fluoro-11,17-dihydroxy-, (11.beta.)-

    76. Fludrocortisone 21-acetate [mi]

    77. 9.alpha.-fluorohydrocortisone 21-acetate

    78. 9.alpha.-fluorohydrocortisone-21-acetate

    79. Ac-18903

    80. Fludrocortisone Acetate [orange Book]

    81. Fludrocortisoni Acetas [who-ip Latin]

    82. Fludrocortisone Acetate [ep Monograph]

    83. C08186

    84. D00986

    85. Fludrocortisone Acetate [usp Monograph]

    86. Q-201121

    87. 9

    88. A-fludrocortisone Acetate;9

    89. A-fluorcortisol Acetate

    90. Fludrocortisone Acetate 100 Microg/ml In Acetonitrile

    91. Q27106657

    92. Wln: L E5 B666 Ov Mutj A1 Bf Cq E1 Fv1ov1 Fq

    93. 9-fluoro-11beta,17-dihydroxy-3,20-dioxopregn-4-en-21-yl Acetate

    94. Pregn-4-ene-3, 9-fluoro-11.beta.,17,21-trihydroxy-, 21-acetate

    95. 9-fluoro-11

    96. A, 17, 21-trihydroxypregn-4-ene-3, 20-dione 21-acetate

    97. Fludrocortisone Acetate, European Pharmacopoeia (ep) Reference Standard

    98. Fludrocortisone Acetate, United States Pharmacopeia (usp) Reference Standard

    99. Pregn-4-ene-3, 21-(acetyloxy)-9-fluoro-11,17-dihydroxy-, (11.beta.)-

    100. Pregn-4-ene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-, 21-acetate

    101. Pregn-4-ene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy-, 21-acetate

    102. 9-fluoro-11.beta.,17,21-trihydroxypregn-4-ene-3,20-dione 21-acetate

    103. Pregn-4-ene-3,20-dione, 21-(acetyloxy)-9-fluoro-11,17-dihydroxy-, (11beta)-

    104. [2-[(9r,10s,11s,13s,17r)-9-fluoro-11,17-dihydroxy-10,13-dimethyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Acetate

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 422.5 g/mol
    Molecular Formula C23H31FO6
    XLogP31.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count4
    Exact Mass422.21046687 g/mol
    Monoisotopic Mass422.21046687 g/mol
    Topological Polar Surface Area101 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity838
    Isotope Atom Count0
    Defined Atom Stereocenter Count7
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameFludrocortisone acetate
    PubMed HealthFludrocortisone Acetate (By mouth)
    Drug ClassesDiagnostic Agent, Adrenocortical Function, Endocrine-Metabolic Agent
    Drug LabelFludrocortisone Acetate Tablets, USP contains fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The che...
    Active IngredientFludrocortisone acetate
    Dosage FormTablet
    RouteOral
    Strength0.1mg
    Market StatusPrescription
    CompanyHikma Pharms; Impax Labs; Barr

    2 of 2  
    Drug NameFludrocortisone acetate
    PubMed HealthFludrocortisone Acetate (By mouth)
    Drug ClassesDiagnostic Agent, Adrenocortical Function, Endocrine-Metabolic Agent
    Drug LabelFludrocortisone Acetate Tablets, USP contains fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The che...
    Active IngredientFludrocortisone acetate
    Dosage FormTablet
    RouteOral
    Strength0.1mg
    Market StatusPrescription
    CompanyHikma Pharms; Impax Labs; Barr

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UDHYAN BUNGLO W,OFF. 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EUR.) (INV. NO. 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    06-Aug-2021
    22-Oct-2024
    KGS
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    ABOUT THIS PAGE

    Fludrocortisone Acetate Manufacturers

    A Fludrocortisone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fludrocortisone Acetate, including repackagers and relabelers. The FDA regulates Fludrocortisone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fludrocortisone Acetate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Fludrocortisone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Fludrocortisone Acetate Suppliers

    A Fludrocortisone Acetate supplier is an individual or a company that provides Fludrocortisone Acetate active pharmaceutical ingredient (API) or Fludrocortisone Acetate finished formulations upon request. The Fludrocortisone Acetate suppliers may include Fludrocortisone Acetate API manufacturers, exporters, distributors and traders.

    click here to find a list of Fludrocortisone Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Fludrocortisone Acetate USDMF

    A Fludrocortisone Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fludrocortisone Acetate active pharmaceutical ingredient (API) in detail. Different forms of Fludrocortisone Acetate DMFs exist exist since differing nations have different regulations, such as Fludrocortisone Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Fludrocortisone Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Fludrocortisone Acetate USDMF includes data on Fludrocortisone Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fludrocortisone Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Fludrocortisone Acetate suppliers with USDMF on PharmaCompass.

    Fludrocortisone Acetate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Fludrocortisone Acetate Drug Master File in Korea (Fludrocortisone Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fludrocortisone Acetate. The MFDS reviews the Fludrocortisone Acetate KDMF as part of the drug registration process and uses the information provided in the Fludrocortisone Acetate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Fludrocortisone Acetate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Fludrocortisone Acetate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Fludrocortisone Acetate suppliers with KDMF on PharmaCompass.

    Fludrocortisone Acetate CEP

    A Fludrocortisone Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Fludrocortisone Acetate Certificate of Suitability (COS). The purpose of a Fludrocortisone Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fludrocortisone Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fludrocortisone Acetate to their clients by showing that a Fludrocortisone Acetate CEP has been issued for it. The manufacturer submits a Fludrocortisone Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fludrocortisone Acetate CEP holder for the record. Additionally, the data presented in the Fludrocortisone Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fludrocortisone Acetate DMF.

    A Fludrocortisone Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fludrocortisone Acetate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Fludrocortisone Acetate suppliers with CEP (COS) on PharmaCompass.

    Fludrocortisone Acetate WC

    A Fludrocortisone Acetate written confirmation (Fludrocortisone Acetate WC) is an official document issued by a regulatory agency to a Fludrocortisone Acetate manufacturer, verifying that the manufacturing facility of a Fludrocortisone Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fludrocortisone Acetate APIs or Fludrocortisone Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Fludrocortisone Acetate WC (written confirmation) as part of the regulatory process.

    click here to find a list of Fludrocortisone Acetate suppliers with Written Confirmation (WC) on PharmaCompass.

    Fludrocortisone Acetate NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Fludrocortisone Acetate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Fludrocortisone Acetate API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Fludrocortisone Acetate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Fludrocortisone Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fludrocortisone Acetate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Fludrocortisone Acetate suppliers with NDC on PharmaCompass.

    Fludrocortisone Acetate GMP

    Fludrocortisone Acetate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Fludrocortisone Acetate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Fludrocortisone Acetate GMP manufacturer or Fludrocortisone Acetate GMP API supplier for your needs.

    Fludrocortisone Acetate CoA

    A Fludrocortisone Acetate CoA (Certificate of Analysis) is a formal document that attests to Fludrocortisone Acetate's compliance with Fludrocortisone Acetate specifications and serves as a tool for batch-level quality control.

    Fludrocortisone Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Fludrocortisone Acetate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Fludrocortisone Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fludrocortisone Acetate EP), Fludrocortisone Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fludrocortisone Acetate USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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