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    Chemistry

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    Also known as: 99592-39-9, Dermofix, Ertaczo, Zalain, Sertaconazole mononitrate, Ginedermofix
    Molecular Formula
    C20H16Cl3N3O4S
    Molecular Weight
    500.8  g/mol
    InChI Key
    HAAITRDZHUANGT-UHFFFAOYSA-N
    FDA UNII
    1DV05410M5
    Sertaconazole Nitrate
    Sertaconazole Nitrate is the nitrate salt form of sertaconazole, a synthetic imidazole derivative with antifungal property. Sertaconazole nitrate inhibits fungal cytochrome P-450 sterol C-14 alpha-demethylation, resulting in the accumulation of fungal 14 alpha-methyl sterols and the inhibition of ergosterol synthesis, an essential component of the cell membrane of fungi. This leads to a disruption of cell membrane permeability and leakage of adenine triphosphate (ATP) and other constituents from fugal cells.
    1 2D Structure

    Sertaconazole Nitrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric acid
    2.1.2 InChI
    InChI=1S/C20H15Cl3N2OS.HNO3/c21-14-4-5-16(18(23)8-14)19(9-25-7-6-24-12-25)26-10-13-11-27-20-15(13)2-1-3-17(20)22;2-1(3)4/h1-8,11-12,19H,9-10H2;(H,2,3,4)
    2.1.3 InChI Key
    HAAITRDZHUANGT-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CC2=C(C(=C1)Cl)SC=C2COC(CN3C=CN=C3)C4=C(C=C(C=C4)Cl)Cl.[N+](=O)(O)[O-]
    2.2 Other Identifiers
    2.2.1 UNII
    1DV05410M5
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Dermofix

    2. Dermoseptic

    3. Ginedermofix

    4. Mykosert

    5. Sertaconazole

    6. Sertaconazole Mononitrate

    7. Zalain

    2.3.2 Depositor-Supplied Synonyms

    1. 99592-39-9

    2. Dermofix

    3. Ertaczo

    4. Zalain

    5. Sertaconazole Mononitrate

    6. Ginedermofix

    7. Dermovit

    8. Fi 7056

    9. Sertaconazole (nitrate)

    10. Fi-7045

    11. 99592-39-9 (nitrate)

    12. 1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric Acid

    13. 1dv05410m5

    14. Fi-7056

    15. 1-[2-[(7-chloro-1-benzothien-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole Nitrate

    16. 1h-imidazole, 1-(2-((7-chlorobenzo(b)thien-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-, Mononitrate

    17. Dermoseptic

    18. 1-{2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl}-1h-imidazole; Nitric Acid

    19. Fisderm

    20. Extens

    21. Onabet

    22. Sr-05000001439

    23. Unii-1dv05410m5

    24. Sertaconazolenitrate

    25. Ertaczo (tn)

    26. Zalain (tn)

    27. 1-(2-((7-chlorobenzo[b]thiophen-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole Nitrate

    28. 1h-imidazole, 1-(2-((7-chlorobenzo(b)thien-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-, Nitrate (1:1)

    29. Ncgc00016966-01

    30. Cas-99592-39-9

    31. Dsstox_cid_25529

    32. Dsstox_rid_80932

    33. Dsstox_gsid_45529

    34. Mls002154122

    35. Schembl261807

    36. Chembl1200725

    37. Dtxsid2045529

    38. Hy-b0736a

    39. Hms1571a12

    40. Hms2098a12

    41. Hms2231n14

    42. Hms3372h01

    43. Hms3715a12

    44. Sertaconazole Nitrate [mi]

    45. Amy32537

    46. Bcp09311

    47. Tox21_110718

    48. Ac-739

    49. Fi7056

    50. Mfcd00918063

    51. S3161

    52. Sertaconazole Nitrate [mart.]

    53. Akos015888158

    54. Akos015964610

    55. Sertaconazole Nitrate [who-dd]

    56. Ccg-221045

    57. 1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole; Nitric Acid

    58. As-14332

    59. Smr001233429

    60. Sertaconazole Nitrate [orange Book]

    61. Sertaconazole Nitrate [ep Monograph]

    62. Ft-0674558

    63. D08510

    64. F20635

    65. A846049

    66. A851341

    67. Sr-05000001439-3

    68. Q27252298

    69. 1-(2-((7-chlorobenzo(b)thien-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole Mononitrate

    70. 1-[2-[(7-chloranyl-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole; Nitric Acid

    71. 1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole,nitric Acid

    2.3.3 Other Synonyms

    1. Sertaconazole

    2. Sertaconazol

    3. Demofix

    2.4 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 500.8 g/mol
    Molecular Formula C20H16Cl3N3O4S
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count6
    Exact Mass498.992710 g/mol
    Monoisotopic Mass498.992710 g/mol
    Topological Polar Surface Area121 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity513
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    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 NameErtaczo
    PubMed HealthSertaconazole (On the skin)
    Drug ClassesAntifungal
    Drug LabelERTACZO (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.Sertaconazole nit...
    Active IngredientSertaconazole nitrate
    Dosage FormCream
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyValeant Luxembourg

    2 of 2  
    Drug NameErtaczo
    PubMed HealthSertaconazole (On the skin)
    Drug ClassesAntifungal
    Drug LabelERTACZO (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.Sertaconazole nit...
    Active IngredientSertaconazole nitrate
    Dosage FormCream
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyValeant Luxembourg

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antifungal Agents

    Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Azoles [CS]; Azole Antifungal [EPC]

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    20-Jan-2021
    29-Nov-2024
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    ABOUT THIS PAGE

    Sertaconazole Nitrate Manufacturers

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

    Sertaconazole Nitrate Suppliers

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

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

    Sertaconazole Nitrate USDMF

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

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

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

    Sertaconazole Nitrate KDMF

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

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

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

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

    Sertaconazole Nitrate CEP

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

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

    Sertaconazole Nitrate WC

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

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

    Sertaconazole Nitrate 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 Sertaconazole Nitrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Sertaconazole Nitrate GMP

    Sertaconazole Nitrate 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 Sertaconazole Nitrate 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 Sertaconazole Nitrate GMP manufacturer or Sertaconazole Nitrate GMP API supplier for your needs.

    Sertaconazole Nitrate CoA

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

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

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