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Chemistry

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Also known as: Lexotanil, Compedium, Durazanil, Lectopam, Lexotan, Creosedin
Molecular Formula
C14H10BrN3O
Molecular Weight
316.15  g/mol
InChI Key
VMIYHDSEFNYJSL-UHFFFAOYSA-N
FDA UNII
X015L14V0O

Bromazepam
One of the BENZODIAZEPINES that is used in the treatment of ANXIETY DISORDERS.
1 2D Structure

Bromazepam

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
7-bromo-5-pyridin-2-yl-1,3-dihydro-1,4-benzodiazepin-2-one
2.1.2 InChI
InChI=1S/C14H10BrN3O/c15-9-4-5-11-10(7-9)14(17-8-13(19)18-11)12-3-1-2-6-16-12/h1-7H,8H2,(H,18,19)
2.1.3 InChI Key
VMIYHDSEFNYJSL-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1C(=O)NC2=C(C=C(C=C2)Br)C(=N1)C3=CC=CC=N3
2.2 Other Identifiers
2.2.1 UNII
X015L14V0O
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Anxyrex

2. Apo Bromazepam

3. Apo-bromazepam

4. Beta, Bromazepam

5. Bromalich

6. Bromaz 1a Pharma

7. Bromazanil

8. Bromazep Von Ct

9. Bromazepam Al

10. Bromazepam Beta

11. Bromazepam Heumann

12. Bromazepam Neuraxpharm

13. Bromazepam Ratiopharm

14. Bromazepam-neuraxpharm

15. Bromazepam-ratiopharm

16. Durazanil

17. Gen Bromazepam

18. Gen-bromazepam

19. Lexatin

20. Lexomil

21. Lexotan

22. Lexotanil

23. Ro 5-3350

24. Ro 53350

25. Von Ct, Bromazep

2.3.2 Depositor-Supplied Synonyms

1. Lexotanil

2. Compedium

3. Durazanil

4. Lectopam

5. Lexotan

6. Creosedin

7. Lexaurin

8. Lexilium

9. Lekotam

10. Lexomil

11. 1812-30-2

12. Calmepam

13. Compendium

14. Normoc

15. La Xvii

16. Ro 5-3350

17. Bromazepamum [inn-latin]

18. Lexatin

19. 7-bromo-5-(2-pyridyl)-3h-1,4-benzodiazepin-2(1h)-one

20. 7-bromo-1,3-dihydro-5-(2-pyridyl)-2h-1,4-benzodiazepin-2-one

21. Bromazepam Civ

22. 2h-1,4-benzodiazepin-2-one, 7-bromo-1,3-dihydro-5-(2-pyridinyl)-

23. Nsc 140669

24. 7-bromo-5-pyridin-2-yl-1,3-dihydro-1,4-benzodiazepin-2-one

25. Ultramidol

26. 7-bromo-1,3-dihydro-5-(2-pyridyl)-2h-1,4-benzdiazepin-2-one

27. Nsc-140669

28. 1,3-dihydro-7-bromo-5-(2-pyridyl)-2h-1,4-benzodiazepin-2-one

29. 2h-1,4-benzodiazepin-2-one, 1,3-dihydro-7-bromo-5-(2-pyridyl)-

30. X015l14v0o

31. 2h-1,4-benzodiazepin-2-one, 7-bromo-1,3-dihydro-5-(2-pyridyl)-

32. 7-bromo-5-(2-pyridyl)-3h-1,4-benzodiaxepin-2(1h)-one

33. Bromazepamum

34. Bromazepamum [latin]

35. Ro-5-3350

36. Bromazepam [usan:inn:ban:jan]

37. Lectopam (tn)

38. Einecs 217-322-4

39. Ro 53350

40. Ro 4-9253

41. Brn 0618645

42. 7-bromo-5-[2-pyridyl]-3h-1,4-benzodiaxepin-2[1h]-one

43. Unii-x015l14v0o

44. Dea No. 2748

45. Bromazepam [mi]

46. Bromazepam [inn]

47. Bromazepam [jan]

48. Bromazepam [usan]

49. Bromazepam [mart.]

50. Bromazepam [who-dd]

51. Schembl43933

52. 5-26-05-00078 (beilstein Handbook Reference)

53. Mls003899212

54. Bromazepam, Analytical Standard

55. Chembl277062

56. Zinc1051

57. Bromazepam (jp17/usan/inn)

58. Bromazepam Civ [usp-rs]

59. Chebi:31302

60. Bromazepam [ep Monograph]

61. Dtxsid40171081

62. 7-bromo-1,4-benzodiazepin-2-one

63. Bromazepam 0.1 Mg/ml In Methanol

64. Bromazepam 1.0 Mg/ml In Methanol

65. Nsc140669

66. Db01558

67. Smr000058724

68. Wln: T67 Gmv Jn Ihj Ce K- Bt6nj

69. D01245

70. 2h-1, 7-bromo-1,3-dihydro-5-(2-pyridyl)-

71. 2h-1, 7-bromo-1,3-dihydro-5-(2-pyridinyl)-

72. 812b302

73. Bromazepam, Drug Standard, 1.0 Mg/ml In Methanol

74. Q422435

75. Bromazepam, European Pharmacopoeia (ep) Reference Standard

76. Bromazepam, United States Pharmacopeia (usp) Reference Standard

77. 7-bromo-5-(pyridin-2-yl)-1h-benzo[e][1,4]diazepin-2(3h)-one

78. 7-bromo-5-(pyridin-2-yl)-2,3-dihydro-1h-1,4-benzodiazepin-2-one

79. (e)-7-bromo-5-(pyridin-2-yl)-1h-benzo[e][1,4]diazepin-2(3h)-one

80. 7-bromo-5-(2-pyridinyl)-1,3-dihydro-2h-1,4-benzodiazepin-2-one #

81. Bromazepam Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 316.15 g/mol
Molecular Formula C14H10BrN3O
XLogP31.7
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count1
Exact Mass315.00072 g/mol
Monoisotopic Mass315.00072 g/mol
Topological Polar Surface Area54.4 Ų
Heavy Atom Count19
Formal Charge0
Complexity385
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

For the short-term treatment of insomnia, short-term treatment of anxiety or panic attacks, if a benzodiazepine is required, and the alleviation of the symptoms of alcohol- and opiate-withdrawal.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Bromazepam is a lipophilic, long-acting benzodiazepine and with sedative, hypnotic, anxiolytic and skeletal muscle relaxant properties. It does not possess any antidepressant qualities. Bromazepam, like other benzodiazepines, presents a risk of abuse, misuse, and dependence. According to many psychiatric experts, Bromazepam has a greater abuse potential than other benzodiazepines because of fast resorption and rapid onset of action.


5.2 MeSH Pharmacological Classification

GABA Modulators

Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)


Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)


5.3 ATC Code

N05BA08

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


N - Nervous system

N05 - Psycholeptics

N05B - Anxiolytics

N05BA - Benzodiazepine derivatives

N05BA08 - Bromazepam


5.4 Absorption, Distribution and Excretion

Absorption

Bioavailability is 84% following oral administration. The time to peak plasma level is 1 - 4 hours. Bromazepam is generally well absorbed after oral administration.


Route of Elimination

Urine (69%), as metabolites


Volume of Distribution

1.56 L/kg


Clearance

0.82 mL/min/kg.


5.5 Metabolism/Metabolites

Hepatically, via oxidative pathways (via an enzyme belonging to the Cytochrome P450 family of enzymes). One of the main metabolites is 3-hydroxybromazepam. It is pharmacologically active and the half life is similar to that of the parent compound.


Bromazepam has known human metabolites that include 3-Hydroxybromazepam.

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


5.6 Biological Half-Life

10-20 hours


5.7 Mechanism of Action

Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.


API Reference Price

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06-Jan-2021
28-Feb-2025
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ABOUT THIS PAGE

Looking for 1812-30-2 / Bromazepam API manufacturers, exporters & distributors?

Bromazepam manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Bromazepam

Synonyms

Lexotanil, Compedium, Durazanil, Lectopam, Lexotan, Creosedin

Cas Number

1812-30-2

Unique Ingredient Identifier (UNII)

X015L14V0O

About Bromazepam

One of the BENZODIAZEPINES that is used in the treatment of ANXIETY DISORDERS.

Lexilium Manufacturers

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

Lexilium Suppliers

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

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

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

Lexilium KDMF

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

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

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

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

Lexilium CEP

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

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

Lexilium WC

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

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

Lexilium GMP

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

Lexilium CoA

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

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

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