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Chemistry

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Also known as: 65-28-1, Phentolamine mesilate, Phentolamine methanesulfonate, Phentolamine (mesylate), Oraverse, Regitine mesylate
Molecular Formula
C18H23N3O4S
Molecular Weight
377.5  g/mol
InChI Key
OGIYDFVHFQEFKQ-UHFFFAOYSA-N
FDA UNII
Y7543E5K9T

Phentolamine Mesylate
A nonselective alpha-adrenergic antagonist. It is used in the treatment of hypertension and hypertensive emergencies, pheochromocytoma, vasospasm of RAYNAUD DISEASE and frostbite, clonidine withdrawal syndrome, impotence, and peripheral vascular disease.
1 2D Structure

Phentolamine Mesylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-[N-(4,5-dihydro-1H-imidazol-2-ylmethyl)-4-methylanilino]phenol;methanesulfonic acid
2.1.2 InChI
InChI=1S/C17H19N3O.CH4O3S/c1-13-5-7-14(8-6-13)20(12-17-18-9-10-19-17)15-3-2-4-16(21)11-15;1-5(2,3)4/h2-8,11,21H,9-10,12H2,1H3,(H,18,19);1H3,(H,2,3,4)
2.1.3 InChI Key
OGIYDFVHFQEFKQ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC=C(C=C1)N(CC2=NCCN2)C3=CC(=CC=C3)O.CS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
Y7543E5K9T
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fentolamin

2. Mesilate, Phentolamine

3. Mesylate, Phentolamine

4. Methanesulfonate, Phentolamine

5. Mono-hydrochloride, Phentolamine

6. Phentolamine

7. Phentolamine Mesilate

8. Phentolamine Methanesulfonate

9. Phentolamine Mono Hydrochloride

10. Phentolamine Mono-hydrochloride

11. Regitine

12. Regityn

13. Rogitine

14. Z-max

2.3.2 Depositor-Supplied Synonyms

1. 65-28-1

2. Phentolamine Mesilate

3. Phentolamine Methanesulfonate

4. Phentolamine (mesylate)

5. Oraverse

6. Regitine Mesylate

7. Phentolamine Methanesulfonate Salt

8. Phentolamine Mesylate [usp]

9. Mesylate Phentolamine

10. 3-(((4,5-dihydro-1h-imidazol-2-yl)methyl)(p-tolyl)amino)phenol Methanesulfonate

11. Nv-101

12. Mls000069487

13. Y7543e5k9t

14. M-(n-(2-imidazolin-2-ylmethyl)-p-toluidino)phenol Monomethanesulfonate (salt)

15. Phenol, 3-(((4,5-dihydro-1h-imidazol-2-yl)methyl)(4-methylphenyl)amino)-, Monomethanesulfonate (salt)

16. Phenol,3-[[(4,5-dihydro-1h-imidazol-2-yl)methyl](4-methylphenyl)amino]-,monomethanesulfonate (salt)

17. Smr000059054

18. 3-[n-(4,5-dihydro-1h-imidazol-2-ylmethyl)-4-methylanilino]phenol;methanesulfonic Acid

19. Phentolamine Mesylate (usp)

20. Vasomax

21. Regitin Methanesulphonate

22. Regitine Methanesulfonate

23. Phenol, M-[n-(2-imidazolin-2-ylmethyl)-p-toluidino]-, Methanesulfonate (1:1)

24. Phentolamine Methanesulphonate

25. Ccris 9022

26. Phentolamine Mesilate [inn:ban]

27. Einecs 200-604-6

28. Vasofem

29. Unii-y7543e5k9t

30. Regitin Mesylate

31. Sr-01000000055

32. Regitine (tn)

33. Z-max

34. Mfcd00134201

35. Opera_id_1599

36. Lopac-p-7561

37. Phentolamine Meslate,(s)

38. Schembl40852

39. Mls001076484

40. Phentolamine, Methyl Sulfonate

41. Regid_for_cid_91430

42. Chembl1200873

43. Hy-b0362a

44. Dtxsid60215315

45. Phentolamine Mesilate (jan/inn)

46. Hms2233a24

47. Hms3263e05

48. Hms3373d03

49. Hms3655b13

50. Hms3884a22

51. Phentolamine Mesilate [jan]

52. Bcp09845

53. Tox21_500982

54. Phentolamine Mesylate [vandf]

55. S2038

56. 3-fluoropyridine-4-boronicacidhydrate

57. Phentolamine Mesilate [mart.]

58. Akos007930193

59. Phentolamine Mesilate [who-dd]

60. Phentolamine Mesylate [usp-rs]

61. Ac-7472

62. Ccg-222286

63. Lp00982

64. 3-[n-(4,5-dihydro-1h-imidazol-2-ylmethyl)-4-methylanilino]phenol; Methanesulfonic Acid

65. Phenol, M-(n-(2-imidazolin-2-ylmethyl)-p-toluidino)-, Monomethanesulfonate (salt)

66. Ncgc00016195-01

67. Ncgc00016195-02

68. Ncgc00094282-01

69. Ncgc00261667-01

70. As-13800

71. Phentolamine Methanesulfonate [mi]

72. Phentolamine Mesylate [orange Book]

73. Phentolamine Mesilate [ep Monograph]

74. Eu-0100982

75. Ft-0603267

76. P1985

77. Phentolamine Mesylate [usp Monograph]

78. Sw196637-3

79. D00509

80. P 7561

81. T72782

82. 134p201

83. A835046

84. Sr-01000000055-3

85. W-104799

86. Q27294332

87. Phentolamine Methanesulfonate Salt, >=98% (tlc), Powder

88. Phentolamine Mesilate, British Pharmacopoeia (bp) Reference Standard

89. 2-[n-(m-hydroxyphenyl)-p-toluidinomethyl]imidazoline Methanesulfonate

90. Phentolamine Mesilate, European Pharmacopoeia (ep) Reference Standard

91. Phentolamine Mesylate, United States Pharmacopeia (usp) Reference Standard

92. 3-(((4,5-dihydro-1h-imidazol-2-yl)methyl)(p-tolyl)amino)phenolmethanesulfonate

93. 3-[[(4,5-dihydro-1h-imidazol-2-yl)methyl](4-methylphenyl)amino]phenol Methanesulfonate

94. 3-[4,5-dihydro-1h-imidazol-2-ylmethyl-(4-methylphenyl)amino]phenol; Methanesulfonic Acid

95. 3-[n-(4,5-dihydro-1h-imidazol-1-ium-2-ylmethyl)-4-methylanilino]phenol;methanesulfonate

96. M-(n-(2-imidazolin-2-ylmethyl)-p-toluidino)phenol Monomethanesulphonate (salt)

97. Phentolamine Mesilate For System Suitability, European Pharmacopoeia (ep) Reference Standard

98. Phentolamine Mesylate, Pharmaceutical Secondary Standard; Certified Reference Material

99. Phenol, 3-(((4,5-dihydro-1h-imidazol-2-yl)methyl)(4-methylphenyl)amino)-, Monomethanesulphonate (salt)

2.4 Create Date
2005-03-27
3 Chemical and Physical Properties
Molecular Weight 377.5 g/mol
Molecular Formula C18H23N3O4S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass377.14092740 g/mol
Monoisotopic Mass377.14092740 g/mol
Topological Polar Surface Area111 Ų
Heavy Atom Count26
Formal Charge0
Complexity456
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NamePhentolamine mesylate
Drug LabelPhentolamine Mesylate for Injection USP, is an antihypertensive, available in vials for intravenous and intramuscular administration. Each vial contains phentolamine mesylate USP, 5 mg and mannitol USP, 25 mg in sterile, lyophilized form.Phentolamine...
Active IngredientPhentolamine mesylate
Dosage FormInjectable
RouteInjection
Strength5mg/vial
Market StatusPrescription
CompanyEurohlth Intl

2 of 4  
Drug NameOraverse
PubMed HealthPhentolamine (Injection)
Drug ClassesAntihypertensive, Diagnostic Agent, Pheochromocytoma, Toxicology-Antidote Agent
Drug LabelPhentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H-imidazol-2-yl)methyl](4-methyl-phenyl)amino]-, methanesulfonate (salt), a non-specific alpha adrenergic blocker.Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a...
Active IngredientPhentolamine mesylate
Dosage FormInjectable
RouteInjection
Strength0.4mg/1.7ml
Market StatusPrescription
CompanySeptodont Holding

3 of 4  
Drug NamePhentolamine mesylate
Drug LabelPhentolamine Mesylate for Injection USP, is an antihypertensive, available in vials for intravenous and intramuscular administration. Each vial contains phentolamine mesylate USP, 5 mg and mannitol USP, 25 mg in sterile, lyophilized form.Phentolamine...
Active IngredientPhentolamine mesylate
Dosage FormInjectable
RouteInjection
Strength5mg/vial
Market StatusPrescription
CompanyEurohlth Intl

4 of 4  
Drug NameOraverse
PubMed HealthPhentolamine (Injection)
Drug ClassesAntihypertensive, Diagnostic Agent, Pheochromocytoma, Toxicology-Antidote Agent
Drug LabelPhentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H-imidazol-2-yl)methyl](4-methyl-phenyl)amino]-, methanesulfonate (salt), a non-specific alpha adrenergic blocker.Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a...
Active IngredientPhentolamine mesylate
Dosage FormInjectable
RouteInjection
Strength0.4mg/1.7ml
Market StatusPrescription
CompanySeptodont Holding

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Adrenergic alpha-Antagonists

Drugs that bind to but do not activate alpha-adrenergic receptors thereby blocking the actions of endogenous or exogenous adrenergic agonists. Adrenergic alpha-antagonists are used in the treatment of hypertension, vasospasm, peripheral vascular disease, shock, and pheochromocytoma. (See all compounds classified as Adrenergic alpha-Antagonists.)


Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
alpha-Adrenergic Blocker [EPC]; Adrenergic alpha-Antagonists [MoA]

API Reference Price

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26-Jun-2021
24-Apr-2024
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ABOUT THIS PAGE

Phentolamine Mesylate Manufacturers

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

Phentolamine Mesylate Suppliers

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

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

Phentolamine Mesylate USDMF

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

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

click here to find a list of Phentolamine Mesylate suppliers with USDMF on PharmaCompass.

Phentolamine Mesylate CEP

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

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

Phentolamine Mesylate WC

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

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

Phentolamine Mesylate 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 Phentolamine Mesylate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Phentolamine Mesylate GMP

Phentolamine Mesylate 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 Phentolamine Mesylate 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 Phentolamine Mesylate GMP manufacturer or Phentolamine Mesylate GMP API supplier for your needs.

Phentolamine Mesylate CoA

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

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

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