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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]

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27-Jan-2021
26-Apr-2025
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USFDA APPLICATION NUMBER - 21077

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DOSAGE - AEROSOL, METERED;INHALATION - 0.045M...DOSAGE - AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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DOSAGE - AEROSOL, METERED;INHALATION - 0.115M...DOSAGE - AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH

USFDA APPLICATION NUMBER - 21254

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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.

Serevent Inhaler and Disks Manufacturers

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

Serevent Inhaler and Disks Suppliers

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

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

Serevent Inhaler and Disks USDMF

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

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

click here to find a list of Serevent Inhaler and Disks suppliers with USDMF on PharmaCompass.

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

Serevent Inhaler and Disks CEP

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

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

Serevent Inhaler and Disks WC

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

click here to find a list of Serevent Inhaler and Disks suppliers with Written Confirmation (WC) on PharmaCompass.

Serevent Inhaler and Disks 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 Serevent Inhaler and Disks as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Serevent Inhaler and Disks suppliers with NDC on PharmaCompass.

Serevent Inhaler and Disks GMP

Serevent Inhaler and Disks 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 Serevent Inhaler and Disks 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 Serevent Inhaler and Disks GMP manufacturer or Serevent Inhaler and Disks GMP API supplier for your needs.

Serevent Inhaler and Disks CoA

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

Serevent Inhaler and Disks CoA mostly includes findings from lab analyses of a specific batch. For each Serevent Inhaler and Disks 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.

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