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Chemistry

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Also known as: 5579-84-0, Betahistine hydrochloride, Betahistine 2hcl, Betahistine hcl, Serc, Betaserc
Molecular Formula
C8H14Cl2N2
Molecular Weight
209.11  g/mol
InChI Key
XVDFMHARQUBJRE-UHFFFAOYSA-N
FDA UNII
49K58SMZ7U

Betahistine Dihydrochloride
A histamine analog and H1 receptor agonist that serves as a vasodilator. It is used in MENIERE DISEASE and in vascular headaches but may exacerbate bronchial asthma and peptic ulcers.
1 2D Structure

Betahistine Dihydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-methyl-2-pyridin-2-ylethanamine;dihydrochloride
2.1.2 InChI
InChI=1S/C8H12N2.2ClH/c1-9-7-5-8-4-2-3-6-10-8;;/h2-4,6,9H,5,7H2,1H3;2*1H
2.1.3 InChI Key
XVDFMHARQUBJRE-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CNCCC1=CC=CC=N1.Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
49K58SMZ7U
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Aequamen

2. Betahistin Al

3. Betahistin Ratiopharm

4. Betahistin Stada

5. Betahistin-ratiopharm

6. Betahistine

7. Betahistine Biphar

8. Betahistine Dihydrobromide

9. Betahistine Hydrochloride

10. Betahistine Mesylate

11. Betahistine Methanesulfonate

12. Betahistine Methanesulphonate

13. Betaserc

14. Betavert

15. By Vertin

16. By-vertin

17. Dihydrobromide, Betahistine

18. Dihydrochloride, Betahistine

19. Extovyl

20. Fidium

21. Hydrochloride, Betahistine

22. Lectil

23. Melopat

24. Mersilon

25. Mesylate, Betahistine

26. Methanesulfonate, Betahistine

27. Methanesulphonate, Betahistine

28. Pt 9

29. Pt-9

30. Pt9

31. Ribrain

32. Serc

33. Vasomotal

34. Vertigon

2.3.2 Depositor-Supplied Synonyms

1. 5579-84-0

2. Betahistine Hydrochloride

3. Betahistine 2hcl

4. Betahistine Hcl

5. Serc

6. Betaserc

7. Microser

8. Antivom

9. 2-pyridineethanamine, N-methyl-, Dihydrochloride

10. Betahistine (dihydrochloride)

11. Pt-9

12. 2-(2-(methylamino)ethyl)pyridine Dihydrochloride

13. Betahistine Hydrochloride [usan:usp]

14. Beta-histine Dihdrochloride

15. N-methyl-n-(2-pyridin-2-ylethyl)amine Dihydrochloride

16. 5579-84-0 (hcl)

17. 49k58smz7u

18. Methyl[2-(2-pyridyl)ethyl]amine Dihydrochloride

19. N-methyl-2-pyridin-2-ylethanamine;dihydrochloride

20. Veserc

21. Mfcd00012813

22. N-methyl-2-(pyridin-2-yl)ethanamine Dihydrochloride

23. Nsc-757397

24. Methyl[2-(pyridin-2-yl)ethyl]amine Dihydrochloride

25. Novo-betahistine

26. Pt 9

27. Betahistine Hydrochloride [usan]

28. Einecs 226-966-5

29. Unii-49k58smz7u

30. Betahistine Dihcl

31. Betahistine Di Hcl

32. Serc (tn)

33. Beta-histine Dihydrochloride

34. N-methyl-2-pyridin-2-ylethanamine Dihydrochloride

35. Schembl60646

36. Spectrum1500670

37. Betahistine Hydrochloride ,(s)

38. Betahistine Hydrochloride (usp)

39. Chembl1446813

40. Hy-b0524a

41. Betahistine Dihydrochloride, 97%

42. Dtxsid10204355

43. Amy40800

44. Bcp13779

45. Ccg-40327

46. S3176

47. Akos015891507

48. Ks-5298

49. Nsc 757397

50. 2-(2-(methylamino)ethyl)pyridine 2hcl

51. Betahistine Dihydrochloride [mi]

52. Betahistine Hydrochloride [mart.]

53. Betahistine Hydrochloride [vandf]

54. Ncgc00095910-01

55. Betahistine Hydrochloride [usp-rs]

56. Betahistine Hydrochloride [who-dd]

57. Db-052800

58. Ft-0622911

59. Ft-0663076

60. Sw196969-3

61. En300-31560

62. 79b840

63. D03102

64. Betahistine Hydrochloride [usp Monograph]

65. A830811

66. Betahistine Dihydrochloride [ep Monograph]

67. N-methyl-2-(2-pyridinyl)ethanamine Dihydrochloride

68. N-methyl-2-(pyridin-2-yl)ethanaminedihydrochloride

69. N-methyl-2-pyridin-2-yl-ethanamine Dihydrochloride

70. Q27259291

71. Betahistine Dihydrochloride, European Pharmacopoeia (ep) Reference Standard

72. Betahistine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 209.11 g/mol
Molecular Formula C8H14Cl2N2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count2
Rotatable Bond Count3
Exact Mass208.0534038 g/mol
Monoisotopic Mass208.0534038 g/mol
Topological Polar Surface Area24.9 Ų
Heavy Atom Count12
Formal Charge0
Complexity83.3
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Histamine Agonists

Drugs that bind to and activate histamine receptors. Although they have been suggested for a variety of clinical applications histamine agonists have so far been more widely used in research than therapeutically. (See all compounds classified as Histamine Agonists.)


Vasodilator Agents

Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)


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Looking for 5579-84-0 / Betahistine Dihydrochloride API manufacturers, exporters & distributors?

Betahistine Dihydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Betahistine Dihydrochloride

Synonyms

5579-84-0, Betahistine hydrochloride, Betahistine 2hcl, Betahistine hcl, Serc, Betaserc

Cas Number

5579-84-0

Unique Ingredient Identifier (UNII)

49K58SMZ7U

About Betahistine Dihydrochloride

A histamine analog and H1 receptor agonist that serves as a vasodilator. It is used in MENIERE DISEASE and in vascular headaches but may exacerbate bronchial asthma and peptic ulcers.

Betahistine Hydrochloride Manufacturers

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

Betahistine Hydrochloride Suppliers

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

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

Betahistine Hydrochloride USDMF

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

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

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

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

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

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

Betahistine Hydrochloride CEP

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

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

Betahistine Hydrochloride WC

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

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

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

Finished drug products

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

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

Betahistine Hydrochloride GMP

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

Betahistine Hydrochloride CoA

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

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

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