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    Chemistry

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    Also known as: 94749-08-3, Salmetedur, Arial, Gr 33343x xinafoate, Salmeterol 1-hydroxy-2-naphthoate, Salmeterolo
    Molecular Formula
    C36H45NO7
    Molecular Weight
    603.7  g/mol
    InChI Key
    XTZNCVSCVHTPAI-UHFFFAOYSA-N
    FDA UNII
    6EW8Q962A5
    Salmeterol Xinafoate
    A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
    1 2D Structure

    Salmeterol Xinafoate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-(hydroxymethyl)-4-[1-hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]phenol;1-hydroxynaphthalene-2-carboxylic acid
    2.1.2 InChI
    InChI=1S/C25H37NO4.C11H8O3/c27-20-23-18-22(13-14-24(23)28)25(29)19-26-15-7-1-2-8-16-30-17-9-6-12-21-10-4-3-5-11-21;12-10-8-4-2-1-3-7(8)5-6-9(10)11(13)14/h3-5,10-11,13-14,18,25-29H,1-2,6-9,12,15-17,19-20H2;1-6,12H,(H,13,14)
    2.1.3 InChI Key
    XTZNCVSCVHTPAI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CC=C(C=C1)CCCCOCCCCCCNCC(C2=CC(=C(C=C2)O)CO)O.C1=CC=C2C(=C1)C=CC(=C2O)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    6EW8Q962A5
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Salmeterol

    2. Serevent

    3. Xinafoate, Salmeterol

    2.3.2 Depositor-Supplied Synonyms

    1. 94749-08-3

    2. Salmetedur

    3. Arial

    4. Gr 33343x Xinafoate

    5. Salmeterol 1-hydroxy-2-naphthoate

    6. Salmeterolo

    7. Salmeterol (xinafoate)

    8. 4-(1-hydroxy-2-((6-(4-phenylbutoxy)hexyl)amino)ethyl)-2-(hydroxymethyl)phenol 1-hydroxy-2-naphthoate

    9. Gr 33343 G

    10. 2-(hydroxymethyl)-4-[1-hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]phenol;1-hydroxynaphthalene-2-carboxylic Acid

    11. Serevent Diskus

    12. 6ew8q962a5

    13. Gr-33343x

    14. Gr-33343 G

    15. Ncgc00094372-03

    16. Asmerole

    17. Betamican

    18. Dilamax

    19. Inaspir

    20. Ultrabeta

    21. Beglan

    22. Dsstox_cid_25798

    23. Dsstox_rid_81137

    24. Dsstox_gsid_45798

    25. Serevent Inhaler And Disks

    26. Salmeterol Xinafoate [usan]

    27. Smr000875207

    28. Cas-94749-08-3

    29. Unii-6ew8q962a5

    30. Salmeterol Xinafoate [usan:usp]

    31. Serevent (tn)

    32. 4-[1-hydroxy-2-[[6-(4-phenylbutoxy)hexyl]amino]ethyl]-2-(hydroxymethyl)phenol 1-hydroxy-2-naphthoate

    33. Salmeterol, 1-hydroxy-2-naphthoate

    34. Mfcd00897708

    35. Schembl18070

    36. (+-)-4-hydroxy-alpha(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-m-xylene-alpha,alpha'-diol 1-hydroxy-2-naphthoate (salt)

    37. Mls001332577

    38. Mls001332578

    39. Chebi:9012

    40. Lipo-202

    41. Chembl1082607

    42. Dtxsid1045798

    43. Salmeterol Xinafoate (jan/usp)

    44. Hms2232i16

    45. Hms3263k22

    46. Hms3676p13

    47. Hms3749i03

    48. Hms3885j19

    49. Salmeterol Xinafoate [jan]

    50. Amy23373

    51. Bcp04778

    52. Salmeterol Xinafoate [vandf]

    53. Tox21_111270

    54. Tox21_501100

    55. S4296

    56. Salmeterol Xinafoate [mart.]

    57. Salmeterol Xinafoate [usp-rs]

    58. Salmeterol Xinafoate [who-dd]

    59. Akos016004957

    60. Tox21_111270_1

    61. Ccg-270203

    62. Cs-1527

    63. Ks-1140

    64. Lp01100

    65. Ncgc00015938-05

    66. Ncgc00094372-01

    67. Ncgc00094372-02

    68. Ncgc00094372-04

    69. Ncgc00261785-01

    70. 1,3-benzenedimethanol, 4-hydroxy-alpha(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-, (+-)-, 1-hydroxy-2-naphthalenecarboxylate (salt)

    71. Hy-17453

    72. Salmeterol Xinafoate [ep Impurity]

    73. Salmeterol Xinafoate [orange Book]

    74. Bcp0726000003

    75. Salmeterol Xinafoate [ep Monograph]

    76. Advair Component Salmeterol Xinafoate

    77. Db-057527

    78. Salmeterol Xinafoate [usp Monograph]

    79. Eu-0101100

    80. Ft-0642283

    81. Salmeterol Xinafoate, >=98% (hplc), Solid

    82. D00687

    83. Lipo-102 Component Salmeterol Xinafoate

    84. R10007

    85. Salmeterol 1-hydroxy-2-naphthoate [mi]

    86. Salmeterol Xinafoate Component Of Advair

    87. Advair Hfa Component Salmeterol Xinafoate

    88. A916443

    89. Sr-01000597359

    90. Q-201697

    91. Salmeterol Xinafoate Component Of Advair Hfa

    92. Sr-01000597359-1

    93. Airduo Respiclick Component Salmeterol Xinafoate

    94. Q27264747

    95. Salmeterol Xinafoate Component Of Airduo Respiclick

    96. Salmeterol Xinafoate, European Pharmacopoeia (ep) Reference Standard

    97. Salmeterol Xinafoate, United States Pharmacopeia (usp) Reference Standard

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

    99. Salmeterol Xinafoate, Pharmaceutical Secondary Standards; Certified Reference Material

    100. (+/-)-4-hydroxy-.alpha.(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-m-xylene-.alpha.,.alpha.'-diol 1-hydroxy-2-naphthoate

    101. 1,3-benzenedimethanol, 4-hydroxy-.alpha.(sup 1)-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-, (+/-)-, 1-hydroxy-2-naphthalenecarboxylate

    102. 4-(1-hydroxy-2-(6-(4-phenylbutoxy)hexylamino)ethyl)-2-(hydroxymethyl)phenol 1-hydroxy-2-naphthoate

    103. 4-hydroxy-?1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol 1-hydroxy-2-naphthalenecarboxylic Acid Salt

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 603.7 g/mol
    Molecular Formula C36H45NO7
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count17
    Exact Mass603.31960277 g/mol
    Monoisotopic Mass603.31960277 g/mol
    Topological Polar Surface Area140 Ų
    Heavy Atom Count44
    Formal Charge0
    Complexity629
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Bronchodilator Agents

    Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)

    Adrenergic beta-2 Receptor Agonists

    Compounds bind to and activate ADRENERGIC BETA-2 RECEPTORS. (See all compounds classified as Adrenergic beta-2 Receptor Agonists.)

    4.2 FDA Pharmacological Classification
    4.2.1 Pharmacological Classes
    beta2-Adrenergic Agonist [EPC]; Adrenergic beta2-Agonists [MoA]

    API Reference Price

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    27-Jan-2021
    26-Apr-2025
    KGS
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    DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH

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    DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH

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    DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0...DOSAGE - POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH

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    DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH

    USFDA APPLICATION NUMBER - 21077

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    DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH

    USFDA APPLICATION NUMBER - 21077

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    ABOUT THIS PAGE

    Looking for 94749-08-3 / Salmeterol Xinafoate API manufacturers, exporters & distributors?

    Salmeterol Xinafoate manufacturers, exporters & distributors 1

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Salmeterol Xinafoate manufacturer or Salmeterol Xinafoate supplier.

    PharmaCompass also assists you with knowing the Salmeterol Xinafoate API Price utilized in the formulation of products. Salmeterol Xinafoate API Price is not always fixed or binding as the Salmeterol Xinafoate Price is obtained through a variety of data sources. The Salmeterol Xinafoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Salmeterol Xinafoate

    Synonyms

    94749-08-3, Salmetedur, Arial, Gr 33343x xinafoate, Salmeterol 1-hydroxy-2-naphthoate, Salmeterolo

    Cas Number

    94749-08-3

    Unique Ingredient Identifier (UNII)

    6EW8Q962A5

    About Salmeterol Xinafoate

    A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Beglan Manufacturers

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

    Beglan Suppliers

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

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

    Beglan USDMF

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

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

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

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

    Beglan CEP

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

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

    Beglan WC

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

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

    Beglan 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 Beglan as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Beglan GMP

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

    Beglan CoA

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

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

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