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    Chemistry

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    Also known as: Flolan, Epoprostenol, Prostacyclin sodium salt, 61849-14-7, Sodium prostacyclin, Prostaglandin i2
    Molecular Formula
    C20H31NaO5
    Molecular Weight
    374.4  g/mol
    InChI Key
    LMHIPJMTZHDKEW-XQYLJSSYSA-M
    FDA UNII
    4K04IQ1OF4
    Epoprostenol Sodium
    A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from PROSTAGLANDIN ENDOPEROXIDES in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension (HYPERTENSION, PULMONARY).
    1 2D Structure

    Epoprostenol Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;(5Z)-5-[(3aR,4R,5R,6aS)-5-hydroxy-4-[(E,3S)-3-hydroxyoct-1-enyl]-3,3a,4,5,6,6a-hexahydrocyclopenta[b]furan-2-ylidene]pentanoate
    2.1.2 InChI
    InChI=1S/C20H32O5.Na/c1-2-3-4-7-14(21)10-11-16-17-12-15(8-5-6-9-20(23)24)25-19(17)13-18(16)22;/h8,10-11,14,16-19,21-22H,2-7,9,12-13H2,1H3,(H,23,24);/q;+1/p-1/b11-10+,15-8-;/t14-,16+,17+,18+,19-;/m0./s1
    2.1.3 InChI Key
    LMHIPJMTZHDKEW-XQYLJSSYSA-M
    2.1.4 Canonical SMILES
    CCCCCC(C=CC1C(CC2C1CC(=CCCCC(=O)[O-])O2)O)O.[Na+]
    2.1.5 Isomeric SMILES
    CCCCC[C@@H](/C=C/[C@H]1[C@@H](C[C@H]2[C@@H]1C/C(=C/CCCC(=O)[O-])/O2)O)O.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    4K04IQ1OF4
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Epoprostanol

    2. Epoprostenol

    3. Epoprostenol Sodium Salt, (5z,9alpha,11alpha,13e,15s)-isomer

    4. Flolan

    5. Prostacyclin

    6. Prostaglandin I(2)

    7. Prostaglandin I2

    8. Veletri

    2.3.2 Depositor-Supplied Synonyms

    1. Flolan

    2. Epoprostenol

    3. Prostacyclin Sodium Salt

    4. 61849-14-7

    5. Sodium Prostacyclin

    6. Prostaglandin I2

    7. U-53217a

    8. U-53,217a

    9. 4k04iq1of4

    10. Cyclo-prostin

    11. 35121-78-9

    12. Epoprostenol Sodium [usan:ban]

    13. Ncgc00167427-01

    14. Einecs 263-273-7

    15. Unii-4k04iq1of4

    16. Floran

    17. U 53,217a

    18. Epoprostenolsodium

    19. Prostacyclin Sodium

    20. Prostaglandin X Sodium

    21. Prostaglandin I2 Na

    22. Chembl962

    23. Dsstox_cid_26617

    24. Dsstox_rid_81769

    25. Sodium (5z,13e,15s)-6,9alpha-epoxy-11alpha,15-dihydroxyprosta-5,13-dien-1-oate

    26. Dsstox_gsid_46617

    27. Schembl41344

    28. Sodium (z)-(3ar,4r,5r,6as)-hexahydro-5-hydroxy-4-((e)-(3s)-3-hydroxy-1-octenyl)-2h-cyclopenta(b)furan-delta(sup 2,delta)-valerate

    29. Bml1-f10

    30. Dtxsid3046617

    31. Epoprostenol Sodium [jan]

    32. 4ua76

    33. Epoprostenol Sodium [usan]

    34. Hms1361k18

    35. Hms3648l14

    36. Epoprostenol Sodium [vandf]

    37. Epoprostenol Sodium [mart.]

    38. Tox21_112431

    39. Epoprostenol Sodium [usp-rs]

    40. Epoprostenol Sodium [who-dd]

    41. Prostacyclin Sodium Salt [mi]

    42. Akos024457370

    43. Epoprostenol Sodium [orange Book]

    44. Prosta-5,13-dien-1-oic Acid, 6,9-epoxy-11,15-dihydroxy-, Sodium Salt, (5z,9alpha,11alpha,13e,15s)-

    45. Cas-61849-14-7

    46. Q27259818

    47. (5z,13e,8r,9s,11r,12r,15s)-6,9-epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic Acid Sodium Salt

    48. Prosta-5,13-dien-1-oic Acid, 6,9-epoxy-11,15-dihydroxy-, Sodium Salt, (5z,9.alpha.,11.alpha.,13e,15s)-

    49. Sodium (z)-(3ar,4r,5r,6as)-hexahydro-5-hydroxy-4-((e)-(3s)-3-hydroxy-1-octenyl)-2h-cyclopenta(b)furan-.delta.(sup 2,.delta.)-valerate

    50. Sodium (z)-5-((3ar,4r,5r,6as)-5-hydroxy-4-((s,e)-3-hydroxyoct-1-enyl)hexahydro-2h-cyclopenta[b]furan-2-ylidene)pentanoate

    2.4 Create Date
    2005-07-19
    3 Chemical and Physical Properties
    Molecular Weight 374.4 g/mol
    Molecular Formula C20H31NaO5
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count10
    Exact Mass374.20691837 g/mol
    Monoisotopic Mass374.20691837 g/mol
    Topological Polar Surface Area89.8 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity491
    Isotope Atom Count0
    Defined Atom Stereocenter Count5
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count2
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameEpoprostenol sodium
    PubMed HealthEpoprostenol (Injection)
    Drug ClassesPeripheral Vasodilator, Platelet Aggregation Inhibitor
    Drug LabelEpoprostenol sodium for injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of epoprostenol sodium for injection contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) e...
    Active IngredientEpoprostenol sodium
    Dosage FormInjectable
    RouteInjection
    Strengtheq 1.5mg base/vial; eq 0.5mg base/vial
    Market StatusPrescription
    CompanyTeva Pharms Usa

    2 of 4  
    Drug NameFlolan
    Drug LabelFLOLAN (epoprostenol sodium) for Injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of FLOLAN contains epoprostenol sodium equivalent to either 0.5mg (500,000ng) or 1.5mg (1,500,000ng) epoprostenol, 3...
    Active IngredientEpoprostenol sodium
    Dosage FormInjectable
    RouteInjection
    Strengtheq 1.5mg base/vial; eq 0.5mg base/vial
    Market StatusPrescription
    CompanyGlaxosmithkline

    3 of 4  
    Drug NameEpoprostenol sodium
    PubMed HealthEpoprostenol (Injection)
    Drug ClassesPeripheral Vasodilator, Platelet Aggregation Inhibitor
    Drug LabelEpoprostenol sodium for injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of epoprostenol sodium for injection contains epoprostenol sodium equivalent to either 0.5 mg (500,000 ng) or 1.5 mg (1,500,000 ng) e...
    Active IngredientEpoprostenol sodium
    Dosage FormInjectable
    RouteInjection
    Strengtheq 1.5mg base/vial; eq 0.5mg base/vial
    Market StatusPrescription
    CompanyTeva Pharms Usa

    4 of 4  
    Drug NameFlolan
    Drug LabelFLOLAN (epoprostenol sodium) for Injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of FLOLAN contains epoprostenol sodium equivalent to either 0.5mg (500,000ng) or 1.5mg (1,500,000ng) epoprostenol, 3...
    Active IngredientEpoprostenol sodium
    Dosage FormInjectable
    RouteInjection
    Strengtheq 1.5mg base/vial; eq 0.5mg base/vial
    Market StatusPrescription
    CompanyGlaxosmithkline

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antihypertensive Agents

    Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

    Platelet Aggregation Inhibitors

    Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system. (See all compounds classified as Platelet Aggregation Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Prostaglandins I [CS]; Vasodilation [PE]; Prostacycline Vasodilator [EPC]
    5.3 ATC Code

    B - Blood and blood forming organs

    B01 - Antithrombotic agents

    B01A - Antithrombotic agents

    B01AC - Platelet aggregation inhibitors excl. heparin

    B01AC09 - Epoprostenol

    API Reference Price

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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"EPOPROSTENOL SODIUM BATCH NO: 2407S015 (QTY 260 GRM)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CAYMAN PHARMA S.R.O","supplierCountry":"CZECH REPUBLIC","foreign_port":"PARANAGUA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"260.00","actualQuantity":"260","unit":"GMS","unitRateFc":"1100","totalValueFC":"320294.8","currency":"EUR","unitRateINR":"103235","date":"05-Sep-2024","totalValueINR":"26841100","totalValueInUsd":"320294.8","indian_port":"Bangalore Air","hs_no":"29375000","bill_no":"5444936","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"PARANAGUA","supplierAddress":"ul Prace 657 27711 Neratovice SDNF SDNF Czech Republic Czech Republic","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734633000,"product":"\\\"FOC\\\" EPOPROSTENOL SODIUM STANDARD - BATCH NO: 2411R01 ( QTY1.4 GRM)\\\"FOC\\\" EPOPROSTENOL SODIUM STANDARD - BATCH NO: 2411R0 ( QTY","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CAYMAN PHARMA S.R.O","supplierCountry":"CZECH REPUBLIC","foreign_port":"PRAGUE - RUZYNE","customer":"VIATRIS","customerCountry":"INDIA","quantity":"1.40","actualQuantity":"1.4","unit":"GMS","unitRateFc":"9424.1","totalValueFC":"13346","currency":"USD","unitRateINR":"810000","date":"20-Dec-2024","totalValueINR":"1134000","totalValueInUsd":"13346","indian_port":"Bangalore Air","hs_no":"29375000","bill_no":"7361959","productDescription":"API","marketType":"REGULATED MARKET","country":"CZECH REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"ul Prace 657 27711 Neratovice SDNF SDNF Czech Republic","customerAddress":"564\/A\/22, ROAD NO.92"}]
    06-Feb-2021
    20-Dec-2024
    GMS
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    DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE/VIAL

    USFDA APPLICATION NUMBER - 22260

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    DOSAGE - INJECTABLE;INJECTION - EQ 1.5MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 1.5MG BASE/VIAL

    USFDA APPLICATION NUMBER - 22260

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    ABOUT THIS PAGE

    Epoprostenol Sodium Manufacturers

    A Epoprostenol Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epoprostenol Sodium, including repackagers and relabelers. The FDA regulates Epoprostenol Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epoprostenol Sodium 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 Epoprostenol Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Epoprostenol Sodium Suppliers

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

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

    Epoprostenol Sodium USDMF

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

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

    click here to find a list of Epoprostenol Sodium suppliers with USDMF on PharmaCompass.

    Epoprostenol Sodium JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Epoprostenol Sodium Drug Master File in Japan (Epoprostenol Sodium JDMF) empowers Epoprostenol Sodium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Epoprostenol Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Epoprostenol Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Epoprostenol Sodium suppliers with JDMF on PharmaCompass.

    Epoprostenol Sodium WC

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

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

    Epoprostenol Sodium 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 Epoprostenol Sodium as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Epoprostenol Sodium 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 Epoprostenol Sodium 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 Epoprostenol Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epoprostenol Sodium NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Epoprostenol Sodium suppliers with NDC on PharmaCompass.

    Epoprostenol Sodium GMP

    Epoprostenol Sodium 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 Epoprostenol Sodium 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 Epoprostenol Sodium GMP manufacturer or Epoprostenol Sodium GMP API supplier for your needs.

    Epoprostenol Sodium CoA

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

    Epoprostenol Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Epoprostenol Sodium 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.

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