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Also known as: 611-75-6, Bromhexine hcl, Bisolvon, Auxit, Bromohexine hydrochloride, Bromhexine (hydrochloride)
Molecular Formula
C14H21Br2ClN2
Molecular Weight
412.59  g/mol
InChI Key
UCDKONUHZNTQPY-UHFFFAOYSA-N
FDA UNII
YC2ZOM3Z8V

Bromhexine Hydrochloride
A mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus. (From Martindale, The Extra Pharmacopoeia, 30th ed, p744)
1 2D Structure

Bromhexine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2,4-dibromo-6-[[cyclohexyl(methyl)amino]methyl]aniline;hydrochloride
2.1.2 InChI
InChI=1S/C14H20Br2N2.ClH/c1-18(12-5-3-2-4-6-12)9-10-7-11(15)8-13(16)14(10)17;/h7-8,12H,2-6,9,17H2,1H3;1H
2.1.3 InChI Key
UCDKONUHZNTQPY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(CC1=C(C(=CC(=C1)Br)Br)N)C2CCCCC2.Cl
2.2 Other Identifiers
2.2.1 UNII
YC2ZOM3Z8V
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Aparsonin

2. Bc, Bromhexin

3. Bisolvon

4. Bromhexin

5. Bromhexin Bc

6. Bromhexin Berlin Chemie

7. Bromhexin Berlin-chemie

8. Bromhexin Berlinchemie

9. Bromhexin Ratiopharm

10. Bromhexin Von Ct

11. Bromhexin-ratiopharm

12. Bromhexine

13. Bromhexine Monohydrochloride

14. Bromhexine, Famel

15. Bromhexinratiopharm

16. Brotussol

17. Ct, Bromhexin Von

18. Darolan

19. Dur Elix

20. Dur-elix

21. Durelix

22. Famel Bromhexine

23. Flegamin

24. Flubron

25. Hustentabs Ratiopharm

26. Hustentabs-ratiopharm

27. Hustentabsratiopharm

28. Hydrochloride, Bromhexine

29. Monohydrochloride, Bromhexine

30. Mucohexine

31. Na 274

32. Na-274

33. Na274

34. Quentan

35. Tesacof

36. Von Ct, Bromhexin

2.3.2 Depositor-Supplied Synonyms

1. 611-75-6

2. Bromhexine Hcl

3. Bisolvon

4. Auxit

5. Bromohexine Hydrochloride

6. Bromhexine (hydrochloride)

7. Broncokin

8. Viscolyt

9. 2,4-dibromo-6-((cyclohexyl(methyl)amino)methyl)aniline Hydrochloride

10. Bromhexine Chloride

11. Bromohexine Monohydrochloride

12. Na 274

13. Bromehexine Hydrochloride

14. Mfcd00056626

15. Yc2zom3z8v

16. Nsc-758383

17. Chebi:31303

18. N-cyclohexyl-n-methyl-(2-amino-3,5-dibromobenzyl)ammonium Chloride

19. Na-274

20. 611-75-6 (hcl)

21. Ncgc00095005-01

22. 2-amino-3,5-dibromo-n-cyclohexyl-n-methylbenzylamine Hydrochloride

23. 2-amino-n-cyclohexyl-3,5-dibromo-n-methylbenzylamine Hydrochloride

24. N-(2-amino-3,5-dibromobenzyl)-n-methyl-cyclohexylammonium Chloride

25. 2,4-dibromo-6-{[cyclohexyl(methyl)amino]methyl}aniline Hydrochloride

26. Benzenemethanamine, 2-amino-3,5-dibromo-n-cyclohexyl-n-methyl-, Monohydrochloride

27. Dsstox_cid_25886

28. Dsstox_rid_81200

29. Dsstox_gsid_45886

30. Bromessina

31. Lisomucin

32. Quentan

33. 2,4-dibromo-6-[[cyclohexyl(methyl)amino]methyl]aniline;hydrochloride

34. Cas-611-75-6

35. Bromessina [italian]

36. Bromihexine Hydrochloride

37. Unii-yc2zom3z8v

38. Ophtolsol

39. Sr-05000001825

40. Bisolvon (tn)

41. Einecs 210-280-8

42. Bromhexine Hydrochloride [usan:jan]

43. Brombenzonium

44. Schembl99613

45. Bromohexine Hydrochloride,(s)

46. Spectrum1503107

47. Chembl1319139

48. Dtxsid0045886

49. Bromhexine For System Suitability

50. Hy-b0372a

51. Hms1922e19

52. Pharmakon1600-01503107

53. Tox21_111385

54. Bromhexine Hydrochloride [mi]

55. Ccg-39304

56. N-(2-amino-3,5-dibromobenzyl)-n-methylcyclohexylamine Hydrochloride

57. Nsc758383

58. S2060

59. Bromhexine Hydrochloride [jan]

60. Akos015906433

61. Benzylamine, 2-amino-n-cyclohexyl-3,5-dibromo-n-methyl-, Hydrochloride

62. Tox21_111385_1

63. Ac-6857

64. Bromhexine Hydrochloride (jp17/usan)

65. Bromhexine Hydrochloride [usan]

66. Ks-5253

67. Nsc 758383

68. Bromhexine Hydrochloride [mart.]

69. Bromhexine Hydrochloride [who-dd]

70. Ncgc00095005-02

71. Ncgc00178520-03

72. 3,5-dibromo-n(sup Alpha)-cyclohexyl-n(sup Alpha)-methyltoluene-alpha,2-diamine Monohydrochloride

73. Sy046825

74. Bromhexine Hydrochloride, >=98.0% (at)

75. B4054

76. Bromhexine Hydrochloride, Analytical Standard

77. Ft-0603492

78. Sw199599-2

79. Bromhexine Hydrochloride [ep Monograph]

80. D01778

81. D70838

82. 611b756

83. A833075

84. Q-200754

85. Sr-05000001825-2

86. Q27114269

87. Bromhexine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

88. 2,4-dibromo-6-((cyclohexyl(methyl)amino)methyl)anilinehydrochloride

89. N-(2-amino-3,5-dibromobenzyl)-n-methylcyclohexanaminium Chloride

90. Bromhexine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

91. 3,5-dibromo-n(alpha)-cyclohexyl-n(alpha)-methyltoluene-alpha,2-diamine Monohydrochloride

92. Bromhexine For System Suitability, European Pharmacopoeia (ep) Reference Standard

93. Bromhexine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

94. 2-amino-3,5-dibromo-n-cyclohexyl-n-methylbenzylamine Hydrochloride, N-(2-amino-3,5-dibromobenzyl)-n-methylcyclohexylamine Hydrochloride

95. 3,5-dibromo-n(sup .alpha.)-cyclohexyl-n(sup .alpha.)-methyltoluene-.alpha.,2-diamine Monohydrochloride

96. Toluene-alpha,2-diamine, 3,5-dibromo-n(sup Alpha)-cyclohexyl-n-(sup Alpha)-methyl-, Monohydrochloride

2.4 Create Date
2006-03-07
3 Chemical and Physical Properties
Molecular Weight 412.59 g/mol
Molecular Formula C14H21Br2ClN2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count2
Rotatable Bond Count3
Exact Mass411.97395 g/mol
Monoisotopic Mass409.97600 g/mol
Topological Polar Surface Area29.3 Ų
Heavy Atom Count19
Formal Charge0
Complexity256
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Expectorants

Agents that increase mucous excretion. Mucolytic agents, that is drugs that liquefy mucous secretions, are also included here. (See all compounds classified as Expectorants.)


CEP/COS

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01

Cophex
Not Confirmed
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02

MAGHREB PHARMA
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03

Cophex
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SURYA REMEDIES PRIVATE LIMITED Ankl...

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CEP 2022-414 - Rev 00
Valid
Chemical
2024-10-02
706
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SURYA REMEDIES PRIVATE LIMITED Ankl...

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Cophex
Not Confirmed
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SURYA REMEDIES PRIVATE LIMITED Ankl...

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Cophex
Not Confirmed

Certificate Number : CEP 2022-414 - Rev 00

Status : Valid

Issue Date : 2024-10-02

Type : Chemical

Substance Number : 706

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04-Jan-2021
28-Feb-2025
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01

EDQM, Council of Europe

Bromhexine for system suitability

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MAGHREB PHARMA
Not Confirmed
MAGHREB PHARMA
Not Confirmed

Bromhexine for system suitability

CAS Number : 611-75-6

Quantity Per Vial : 15 mg

Sale Unit : 1

Order Code : Y0001757

Batch No : 2

Price (€) : 79

Storage : +5°C ± 3°C

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02

EDQM, Council of Europe

Bromhexine hydrochloride

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MAGHREB PHARMA
Not Confirmed
MAGHREB PHARMA
Not Confirmed

Bromhexine hydrochloride

CAS Number : 611-75-6

Quantity Per Vial : 200 mg

Sale Unit : 1

Order Code : B1145000

Batch No : 4

Price (€) : 79

Storage : +5°C ± 3°C

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ABOUT THIS PAGE

Looking for 611-75-6 / Bromhexine Hydrochloride API manufacturers, exporters & distributors?

Bromhexine Hydrochloride manufacturers, exporters & distributors 1

22

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

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

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

API | Excipient name

Bromhexine Hydrochloride

Synonyms

611-75-6, Bromhexine hcl, Bisolvon, Auxit, Bromohexine hydrochloride, Bromhexine (hydrochloride)

Cas Number

611-75-6

Unique Ingredient Identifier (UNII)

YC2ZOM3Z8V

About Bromhexine Hydrochloride

A mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus. (From Martindale, The Extra Pharmacopoeia, 30th ed, p744)

Bisolvon Manufacturers

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

Bisolvon Suppliers

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

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

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

Bisolvon CEP

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

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

Bisolvon WC

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

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

Bisolvon 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 Bisolvon as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Bisolvon GMP

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

Bisolvon CoA

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

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

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