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    Chemistry

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    Also known as: Ethambutol dihydrochloride, Ethambutol hcl, 1070-11-7, Myambutol, Dadibutol, Dexambutol
    Molecular Formula
    C10H26Cl2N2O2
    Molecular Weight
    277.23  g/mol
    InChI Key
    AUAHHJJRFHRVPV-BZDVOYDHSA-N
    FDA UNII
    QE4VW5FO07
    Ethambutol Dihydrochloride
    An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863)
    1 2D Structure

    Ethambutol Dihydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[2-[[(2S)-1-hydroxybutan-2-yl]amino]ethylamino]butan-1-ol;dihydrochloride
    2.1.2 InChI
    InChI=1S/C10H24N2O2.2ClH/c1-3-9(7-13)11-5-6-12-10(4-2)8-14;;/h9-14H,3-8H2,1-2H3;2*1H/t9-,10-;;/m0../s1
    2.1.3 InChI Key
    AUAHHJJRFHRVPV-BZDVOYDHSA-N
    2.1.4 Canonical SMILES
    CCC(CO)NCCNC(CC)CO.Cl.Cl
    2.1.5 Isomeric SMILES
    CC[C@@H](CO)NCCN[C@@H](CC)CO.Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    QE4VW5FO07
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Dexambutol

    2. Emb Fatol

    3. Emb Hefa

    4. Emb-fatol

    5. Emb-hefa

    6. Etambutol Llorente

    7. Ethambutol

    8. Etibi

    9. Hydrochloride, Ethambutol

    10. Llorente, Etambutol

    11. Miambutol

    12. Myambutol

    2.3.2 Depositor-Supplied Synonyms

    1. Ethambutol Dihydrochloride

    2. Ethambutol Hcl

    3. 1070-11-7

    4. Myambutol

    5. Dadibutol

    6. Dexambutol

    7. Etibi

    8. Ethambutol (dihydrochloride)

    9. Servambutol

    10. Etapiam

    11. Mycobutol

    12. Tambutol

    13. Ebutol

    14. Cl 40881

    15. Tibutol

    16. (2s,2's)-2,2'-(ethane-1,2-diylbis(azanediyl))bis(butan-1-ol) Dihydrochloride

    17. Jng307dj5x

    18. Qe4vw5fo07

    19. Ethambutol Dihydrochloride, Dl-

    20. (+)-2,2'-(ethylenediimino)-di-1-butanol Dihydrochloride

    21. Nsc-757022

    22. Cl-40881

    23. 22196-75-4

    24. Dsstox_cid_25345

    25. Dsstox_rid_80813

    26. Dsstox_gsid_45345

    27. Ethambutol 2hcl

    28. Emb Dihydrochloride

    29. Chebi:4878

    30. (2s)-2-[2-[[(1s)-1-(hydroxymethyl)propyl]amino]ethylamino]butan-1-ol Dihydrochloride

    31. (2s)-2-[2-[[(2s)-1-hydroxybutan-2-yl]amino]ethylamino]butan-1-ol;dihydrochloride

    32. Ccris 6606

    33. Ncgc00178864-03

    34. Einecs 213-970-7

    35. Unii-jng307dj5x

    36. Unii-qe4vw5fo07

    37. (+-)-ethambutol Dihydrochloride

    38. Myambutol (tn)

    39. Ethambutol Hydrochloride [usan:usp:jan]

    40. Ethambutoli Hydrochloridum

    41. Emb

    42. Ncgc00016560-01

    43. Cas-1070-11-7

    44. (2s)-2-[(2-{[(2s)-1-hydroxybutan-2-yl]amino}ethyl)amino]butan-1-ol Dihydrochloride

    45. Schembl650049

    46. Spectrum1500288

    47. Chembl3140361

    48. Dtxsid4045345

    49. Hy-b0535a

    50. (+-)-2,2'-(ethylenediimino)-di-1-butanol Dihydrochloride

    51. Hms1920m18

    52. Kuc109574c

    53. (s-(r*,r*))-2,2'-(ethylenediimino)dibutan-1-ol Dihydrochloride

    54. Ksc-27-052b

    55. Tox21_110494

    56. 1-butanol, 2,2'-(ethylenediimino)di-, Dihydrochloride, (+)-

    57. Ccg-40232

    58. Mfcd21364080

    59. S4004

    60. Ethambutol Hydrochloride (jp17/usp)

    61. Ethambutol Hydrochloride [jan]

    62. 1-butanol, (1,2-ethanediyldiimino)bis-, Dihydrochloride, (r*,r*)-(+-)-

    63. Akos024258527

    64. Tox21_110494_1

    65. Cl40881

    66. Ethambutol Dihydrochloride [mi]

    67. Ethambutol Hydrochloride [usan]

    68. Nsc 757022

    69. 1-butanol, 2,2'-(1,2-ethanediyldiimino)bis-, Dihydrochloride, (r-(r*,r*))-

    70. 1-butanol, 2,2'-(1,2-ethanediyldiimino)bis-, Dihydrochloride, (s-(r*,r*))-

    71. Ethambutol Hydrochloride [mart.]

    72. Ethambutol Hydrochloride [vandf]

    73. Ethambutol Hydrochloride [usp-rs]

    74. Ethambutol Hydrochloride [who-ip]

    75. Ethambutol Dihydrochloride [who-dd]

    76. Ethambutol Dihydrochloride, Antimycobacterial

    77. E1011

    78. Sw219109-1

    79. Ethambutol Hydrochloride [ep Impurity]

    80. Ethambutol Hydrochloride [orange Book]

    81. D00878

    82. Ethambutol Hydrochloride [ep Monograph]

    83. Ethambutol Hydrochloride [usp Monograph]

    84. Ethambutoli Hydrochloridum [who-ip Latin]

    85. A895715

    86. Q27106530

    87. Z1558572530

    88. 2,2'-(1,2-ethanediyldiimino)bis-1-butanol Dihydrochloride

    89. 2,2'-[ethane-1,2-diyldi(imino)]dibutan-1-ol Dihydrochloride

    90. (s,s)-2,2'-(1,2-ethanediyldiimino)bis-1-butanol Dihydrochloride

    91. (s,s)-n,n'-bis(1-hydroxy-2-butyl)ethylenediamine Dihydrochloride

    92. 1-butanol, 2,2'-(1,2-ethanediyldiimino)bis-, Dihydrochloride, (r*,r*)-

    93. 1-butanol, 2,2'-(ethylenediimino)di-, Dihydrochloride, (+-)-

    94. Ethambutol Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    95. 1-butanol, 2,2'(1,2-ethanediyldiimino)bis-, Dihydrochloride, (-(r*,r*))

    96. 1-butanol, 2,2'-(1,2-ethanediyldiimino)bis-, Dihydrochloride, (2r,2'r)-rel-

    97. 1-butanol, 2,2'-(1,2-ethanediyldiimino)bis-, Hydrochloride (1:2), (2s,2's)-

    98. Ethambutol For System Suitability, European Pharmacopoeia (ep) Reference Standard

    99. Ethambutol Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    100. Ethambutol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    101. 29326-86-1

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 277.23 g/mol
    Molecular Formula C10H26Cl2N2O2
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count9
    Exact Mass276.1371335 g/mol
    Monoisotopic Mass276.1371335 g/mol
    Topological Polar Surface Area64.5 Ų
    Heavy Atom Count16
    Formal Charge0
    Complexity109
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameEthambutol hydrochloride
    Active IngredientEthambutol hydrochloride
    Dosage FormTablet
    RouteOral
    Strength100mg; 400mg
    Market StatusPrescription
    CompanyLupin; Barr

    2 of 2  
    Drug NameEthambutol hydrochloride
    Active IngredientEthambutol hydrochloride
    Dosage FormTablet
    RouteOral
    Strength100mg; 400mg
    Market StatusPrescription
    CompanyLupin; Barr

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antitubercular Agents

    Drugs used in the treatment of tuberculosis. They are divided into two main classes: "first-line" agents, those with the greatest efficacy and acceptable degrees of toxicity used successfully in the great majority of cases; and "second-line" drugs used in drug-resistant cases or those in which some other patient-related condition has compromised the effectiveness of primary therapy. (See all compounds classified as Antitubercular Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Antimycobacterial [EPC]

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 100MG

    USFDA APPLICATION NUMBER - 16320

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    DOSAGE - TABLET;ORAL - 400MG

    USFDA APPLICATION NUMBER - 16320

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    ABOUT THIS PAGE

    Ethambutol Hydrochloride Manufacturers

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

    Ethambutol Hydrochloride Suppliers

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

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

    Ethambutol Hydrochloride USDMF

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

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

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

    Ethambutol Hydrochloride 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 Ethambutol Hydrochloride Drug Master File in Japan (Ethambutol Hydrochloride JDMF) empowers Ethambutol Hydrochloride 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 Ethambutol Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ethambutol Hydrochloride 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 Ethambutol Hydrochloride suppliers with JDMF on PharmaCompass.

    Ethambutol Hydrochloride KDMF

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

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

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

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

    Ethambutol Hydrochloride CEP

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

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

    Ethambutol Hydrochloride WC

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

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

    Ethambutol Hydrochloride 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 Ethambutol Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Ethambutol Hydrochloride GMP

    Ethambutol Hydrochloride 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 Ethambutol Hydrochloride 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 Ethambutol Hydrochloride GMP manufacturer or Ethambutol Hydrochloride GMP API supplier for your needs.

    Ethambutol Hydrochloride CoA

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

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

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