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    Chemistry

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    Also known as: Sodium estrone sulfate, Estrone sodium sulfate, 438-67-5, Estrone sodium sulphate, Estrone 3-sulfate sodium salt, Conestoral
    Molecular Formula
    C18H21NaO5S
    Molecular Weight
    372.4  g/mol
    InChI Key
    VUCAHVBMSFIGAI-ZFINNJDLSA-M
    FDA UNII
    6K6FDA543A
    Conjugated Estrogens
    1 2D Structure

    Conjugated Estrogens

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;[(8R,9S,13S,14S)-13-methyl-17-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-yl] sulfate
    2.1.2 InChI
    InChI=1S/C18H22O5S.Na/c1-18-9-8-14-13-5-3-12(23-24(20,21)22)10-11(13)2-4-15(14)16(18)6-7-17(18)19;/h3,5,10,14-16H,2,4,6-9H2,1H3,(H,20,21,22);/q;+1/p-1/t14-,15-,16+,18+;/m1./s1
    2.1.3 InChI Key
    VUCAHVBMSFIGAI-ZFINNJDLSA-M
    2.1.4 Canonical SMILES
    CC12CCC3C(C1CCC2=O)CCC4=C3C=CC(=C4)OS(=O)(=O)[O-].[Na+]
    2.1.5 Isomeric SMILES
    C[C@]12CC[C@H]3[C@H]([C@@H]1CCC2=O)CCC4=C3C=CC(=C4)OS(=O)(=O)[O-].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    6K6FDA543A
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Estrone Sulfate

    2. Estrone Sulfate, 14c-labeled

    3. Estrone Sulfate, 16-(14)c-labeled

    4. Estrone Sulfate, Ammonium Salt

    5. Estrone Sulfate, Potassium Salt

    6. Estrone Sulfate, Sodium Salt

    7. Estrone-3-sulfate

    8. Evex

    9. Oestrone Sulphate

    10. Potassium Estrone Sulfate

    11. Sodium Estrone Sulfate

    2.3.2 Depositor-Supplied Synonyms

    1. Sodium Estrone Sulfate

    2. Estrone Sodium Sulfate

    3. 438-67-5

    4. Estrone Sodium Sulphate

    5. Estrone 3-sulfate Sodium Salt

    6. Conestoral

    7. Hyhorin

    8. Morestin

    9. Estrone Sulfate Sodium

    10. Par Estro

    11. Estrone Sulfate Sodium Salt

    12. Estrone-3-sulfate Sodium Salt

    13. Sodium Estrone Sulphate

    14. Sodium Estrone 3-sulfate

    15. Oestrone-3-sulphate Sodium Salt

    16. Estrogenic Substances (conjugated)

    17. Estra-1,3,5(10)-trien-17-one, 3-(sulfooxy)-, Sodium Salt

    18. 6k6fda543a

    19. Chebi:8389

    20. 17-oxoestra-1,3,5(10)-trien-3-yl Sodium Sulfate

    21. Nsc-18313

    22. Estrone Sulfate (sodium)

    23. Sodium;[(8r,9s,13s,14s)-13-methyl-17-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-3-yl] Sulfate

    24. Sodium Estrone-3-sulfate

    25. 1,3,5(10)-estratrien-3-ol-17-one Sulphate, Sodium Salt

    26. Smr000058772

    27. Einecs 207-120-4

    28. Nsc 18313

    29. Unii-6k6fda543a

    30. Conjugated Estrogens: Sodium Estrone Sulfate

    31. Estrone3-sulfatesodiumsalt

    32. Sodium (8r,9s,13s,14s)-13-methyl-17-oxo-7,8,9,11,12,13,14,15,16,17-decahydro-6h-cyclopenta(a)phenanthren-3-yl Sulfate

    33. Sodium (8r,9s,13s,14s)-13-methyl-17-oxo-7,8,9,11,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthren-3-yl Sulfate

    34. Sodium 17-oxoestra-1(10),2,4-trien-3-yl Sulfate

    35. Estrone, Hydrogen Sulfate, Sodium Salt

    36. Schembl4616

    37. Mls000069757

    38. Mls001424259

    39. Chembl2106240

    40. Dtxsid00860005

    41. Dtxsid70881181

    42. Hms2052j05

    43. Hms2232j23

    44. Discontinued. See E889070

    45. Akos015967195

    46. Estrone Sodium Sulfate [vandf]

    47. Ccg-101163

    48. Hy-113293b

    49. Nc00413

    50. Estrone Sodium Sulfate [who-dd]

    51. Cs-0108249

    52. D00312

    53. Q4118295

    54. Sodium 17-oxoestra-1,3,5(10)-trien-3-yl Sulfate

    55. Estrone 3-sulfate Sodium Salt, Stabilized With Tris

    56. Estra-1,3,5(10)-trien-17-one 3-(sulfooxy) Sodium Salt

    57. Sodium [(8r,9s,13s,14s)-13-methyl-17-oxo-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-3-yl] Sulfate

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 372.4 g/mol
    Molecular Formula C18H21NaO5S
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass372.10073922 g/mol
    Monoisotopic Mass372.10073922 g/mol
    Topological Polar Surface Area91.9 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity630
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NamePremarin
    PubMed HealthConjugated Estrogens (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Musculoskeletal Agent
    Drug LabelPremarin Intravenous (conjugated estrogens, USP) for injection contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average com...
    Active IngredientEstrogens, conjugated
    Dosage FormTablet; Cream; Injectable
    Routeoral; Injection; Oral; Topical, vaginal
    Strength25mg/vial; 0.45mg; 1.25mg; 0.625mg/gm; 0.625mg; 0.9mg; 0.3mg
    Market StatusPrescription
    CompanyWyeth Pharms

    2 of 2  
    Drug NamePremarin
    PubMed HealthConjugated Estrogens (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Musculoskeletal Agent
    Drug LabelPremarin Intravenous (conjugated estrogens, USP) for injection contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average com...
    Active IngredientEstrogens, conjugated
    Dosage FormTablet; Cream; Injectable
    Routeoral; Injection; Oral; Topical, vaginal
    Strength25mg/vial; 0.45mg; 1.25mg; 0.625mg/gm; 0.625mg; 0.9mg; 0.3mg
    Market StatusPrescription
    CompanyWyeth Pharms

    API Reference Price

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    06-May-2021
    14-Aug-2024
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    DOSAGE - TABLET;ORAL - EQ 20MG BASE;0.45MG

    USFDA APPLICATION NUMBER - 22247

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    DOSAGE - TABLET;ORAL - 0.3MG

    USFDA APPLICATION NUMBER - 4782

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    DOSAGE - TABLET;ORAL - 0.45MG

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    DOSAGE - TABLET;ORAL - 0.625MG

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    DOSAGE - TABLET;ORAL - 0.9MG

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    DOSAGE - TABLET;ORAL - 1.25MG

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    ABOUT THIS PAGE

    Premarin Manufacturers

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

    Premarin Suppliers

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

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

    Premarin USDMF

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

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

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

    Premarin KDMF

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

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

    After submitting a Premarin 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 Premarin API can apply through the Korea Drug Master File (KDMF).

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

    Premarin CEP

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

    A Premarin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Premarin 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 Premarin suppliers with CEP (COS) on PharmaCompass.

    Premarin WC

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

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

    Premarin 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 Premarin as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Premarin GMP

    Premarin 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 Premarin 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 Premarin GMP manufacturer or Premarin GMP API supplier for your needs.

    Premarin CoA

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

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

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