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Chemistry

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Also known as: 90729-43-4, Kestine, Ebastel, Ebastin, Kestin, Bactil
Molecular Formula
C32H39NO2
Molecular Weight
469.7  g/mol
InChI Key
MJJALKDDGIKVBE-UHFFFAOYSA-N
FDA UNII
TQD7Q784P1

Ebastine
Ebastine is under investigation for the treatment of Irritable Bowel Syndrome (IBS). Ebastine has been investigated for the treatment of Urticaria.
1 2D Structure

Ebastine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-(4-benzhydryloxypiperidin-1-yl)-1-(4-tert-butylphenyl)butan-1-one
2.1.2 InChI
InChI=1S/C32H39NO2/c1-32(2,3)28-18-16-25(17-19-28)30(34)15-10-22-33-23-20-29(21-24-33)35-31(26-11-6-4-7-12-26)27-13-8-5-9-14-27/h4-9,11-14,16-19,29,31H,10,15,20-24H2,1-3H3
2.1.3 InChI Key
MJJALKDDGIKVBE-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)(C)C1=CC=C(C=C1)C(=O)CCCN2CCC(CC2)OC(C3=CC=CC=C3)C4=CC=CC=C4
2.2 Other Identifiers
2.2.1 UNII
TQD7Q784P1
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-diphenylmethoxy-1-(3-(4-tert-butylbenzoyl)propyl)piperidine

2. Bactil

3. Busidril

4. Ebastel

5. Evastel

6. Kestin

7. Kestine

8. Las W-090

2.3.2 Depositor-Supplied Synonyms

1. 90729-43-4

2. Kestine

3. Ebastel

4. Ebastin

5. Kestin

6. Bactil

7. Las W-090

8. Rp 64305

9. 4-(4-benzhydryloxypiperidin-1-yl)-1-(4-tert-butylphenyl)butan-1-one

10. Las-w-090

11. 1-(4-tert-butylphenyl)-4-[4-(diphenylmethoxy)piperidin-1-yl]butan-1-one

12. Las-w 090;rp64305

13. Rp-64305

14. Chembl305660

15. Tqd7q784p1

16. 4-(4-(benzhydryloxy)piperidin-1-yl)-1-(4-(tert-butyl)phenyl)butan-1-one

17. Rp64305

18. Ncgc00164603-01

19. Evastel

20. Dsstox_cid_26472

21. Dsstox_rid_81644

22. Dsstox_gsid_46472

23. Ebastinum [latin]

24. Ebastina [spanish]

25. Ebastina

26. Ebastinum

27. Estivan

28. Bastel

29. Cas-90729-43-4

30. Unii-tqd7q784p1

31. Ebastine [usan:inn:ban]

32. 4-(4-(benzhydryloxy)piperidin-1-yl)-1-(4-tert-butylphenyl)butan-1-one

33. 4-[4-(benzhydryloxy)piperidin-1-yl]-1-(4-tert-butylphenyl)butan-1-one

34. 4-diphenylmethoxy-1-(3-(4-tert-butylbenzoyl)propyl)piperidine

35. Las-w 090

36. No-sedat

37. Kestine (tn)

38. Mfcd00865661

39. 4'-tert-butyl-4-(4-(diphenylmethoxy)piperidino)butyrophenone

40. Ebastine [usan]

41. Ebastine [inn]

42. Ebastine [jan]

43. Ebastine [mi]

44. 4-(4-benzhydryloxy-1-piperidyl)-1-(4-tert-butylphenyl)butan-1-one

45. Ebastine [mart.]

46. Ebastine [who-dd]

47. 1-(4-(1,1-dimethylethyl)phenyl)-4-(4-(diphenylmethoxy)-1-piperidinyl)-1-butanone

48. Schembl18467

49. Ebastine [ep Impurity]

50. Ebastine (jp17/usan/inn)

51. Ebastine [ep Monograph]

52. Dtxsid6046472

53. Bdbm22873

54. Chebi:31528

55. Hms3261i03

56. Hms3887c19

57. Bcp08300

58. Hy-b0674

59. Zinc3781952

60. Tox21_112225

61. Tox21_500361

62. Bbl029069

63. Ebastine, >=98% (hplc), Solid

64. S4262

65. Stk624411

66. Akos005557491

67. Tox21_112225_1

68. Ccg-221665

69. Db11742

70. Ks-1349

71. Lp00361

72. Sdccgsbi-0633701.p001

73. 1-butanone, 1-(4-(1,1-dimethylethyl)phenyl)-4-(4-(diphenylmethoxy)-1-piperidinyl)-

74. Ncgc00164603-02

75. Ncgc00164603-04

76. Ncgc00164603-05

77. Ncgc00164603-11

78. Ncgc00261046-01

79. Ac-15213

80. Ac-30629

81. Be164400

82. Db-057220

83. E0925

84. Ft-0630975

85. W-090

86. A14946

87. C77079

88. D01478

89. Ab01325291-02

90. 729e434

91. A843625

92. Sr-01000883997

93. Q-201053

94. Q2327739

95. Sr-01000883997-1

96. 4-diphenylmethoxy-1[3-(4-tert-butylbenzoyl)propyl]-piperidine

97. Ebastine, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 469.7 g/mol
Molecular Formula C32H39NO2
XLogP37.2
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count3
Rotatable Bond Count10
Exact Mass469.298079487 g/mol
Monoisotopic Mass469.298079487 g/mol
Topological Polar Surface Area29.5 Ų
Heavy Atom Count35
Formal Charge0
Complexity594
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)


4.2 ATC Code

R06AX22

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


R - Respiratory system

R06 - Antihistamines for systemic use

R06A - Antihistamines for systemic use

R06AX - Other antihistamines for systemic use

R06AX22 - Ebastine


4.3 Metabolism/Metabolites

Ebastine has known human metabolites that include 4-(4-tert-butylphenyl)-4-oxobutanal and Deslakylebastine.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


API Reference Price

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17-Jan-2022
09-Apr-2025
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ABOUT THIS PAGE

Looking for 90729-43-4 / Ebastine API manufacturers, exporters & distributors?

Ebastine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ebastine 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 Ebastine manufacturer or Ebastine supplier for your needs.

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

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

API | Excipient name

Ebastine

Synonyms

90729-43-4, Kestine, Ebastel, Ebastin, Kestin, Bactil

Cas Number

90729-43-4

Unique Ingredient Identifier (UNII)

TQD7Q784P1

About Ebastine

Ebastine is under investigation for the treatment of Irritable Bowel Syndrome (IBS). Ebastine has been investigated for the treatment of Urticaria.

Ebastine Manufacturers

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

Ebastine Suppliers

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

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

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

Ebastine KDMF

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

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

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

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

Ebastine CEP

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

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

Ebastine WC

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

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

Ebastine GMP

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

Ebastine CoA

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

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

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