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Chemistry

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Also known as: 116-38-1, N-ethyl-3-hydroxy-n,n-dimethylbenzenaminium chloride, Antirex, Tensilon chloride, Reversol, Enlon
Molecular Formula
C10H16ClNO
Molecular Weight
201.69  g/mol
InChI Key
BXKDSDJJOVIHMX-UHFFFAOYSA-N
FDA UNII
QO611KSM5P

Edrophonium Chloride
A rapid-onset, short-acting cholinesterase inhibitor used in cardiac arrhythmias and in the diagnosis of myasthenia gravis. It has also been used as an antidote to curare principles.
1 2D Structure

Edrophonium Chloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
ethyl-(3-hydroxyphenyl)-dimethylazanium;chloride
2.1.2 InChI
InChI=1S/C10H15NO.ClH/c1-4-11(2,3)9-6-5-7-10(12)8-9;/h5-8H,4H2,1-3H3;1H
2.1.3 InChI Key
BXKDSDJJOVIHMX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC[N+](C)(C)C1=CC(=CC=C1)O.[Cl-]
2.2 Other Identifiers
2.2.1 UNII
QO611KSM5P
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bromide, Edrophonium

2. Chloride, Edrophonium

3. Edrophonium

4. Edrophonium Bromide

5. Edroponium

6. Tensilon

2.3.2 Depositor-Supplied Synonyms

1. 116-38-1

2. N-ethyl-3-hydroxy-n,n-dimethylbenzenaminium Chloride

3. Antirex

4. Tensilon Chloride

5. Reversol

6. Enlon

7. Edrophonii Chloridum

8. Ethyl(m-hydroxyphenyl)dimethylammonium Chloride

9. Cloruro De Edrofonio

10. Chlorure D'edrophonium

11. Edrophonium (chloride)

12. Benzenaminium, N-ethyl-3-hydroxy-n,n-dimethyl-, Chloride

13. N-ethyl-3-hydroxy-n,n-dimethylanilinium Chloride

14. Nsc-759577

15. Qo611ksm5p

16. Mls000028677

17. Chebi:4759

18. Ethyl-(3-hydroxyphenyl)-dimethylazanium;chloride

19. Edrophone Chloride

20. Smr000058672

21. Dsstox_cid_2978

22. (3-hydroxyphenyl)dimethylethylammonium Chloride

23. Dsstox_rid_76815

24. 3-hydroxy-n,n-dimethyl-n-ethylanilinium Chloride

25. Dsstox_gsid_22978

26. Edrofonio Cloruro

27. Edrofonio Cloruro [dcit]

28. Tensilon Preservative Free

29. Edrophonii Chloridum [inn-latin]

30. Sr-01000000275

31. Ncgc00015409-02

32. Cas-116-38-1

33. Cloruro De Edrofonio [inn-spanish]

34. Einecs 204-138-4

35. Chlorure D'edrophonium [inn-french]

36. Edrophonium Chloride Preservative Free

37. Unii-qo611ksm5p

38. Tensilon (tn)

39. Prestwick_192

40. Ammonium, Dimethylethyl(m-hydroxyphenyl)-, Chloride

41. Enlon (tn)

42. Edrophonium Chloride [usp:inn:ban:jan]

43. Edrophoniumchloride

44. Opera_id_1421

45. Chembl1128

46. Schembl34789

47. Mls001074086

48. Spectrum2300219

49. Dtxsid1022978

50. Hms502i11

51. Ammonium, Ethyl(m-hydroxyphenyl)dimethyl-, Chloride

52. Edrophonium Chloride [mi]

53. Edrophonium Chloride [inn]

54. Edrophonium Chloride [jan]

55. Hms1568a08

56. Hms1922j20

57. Hms2093n16

58. Hms2095a08

59. Hms2233g08

60. Hms3259e12

61. Hms3261h03

62. Hms3369m15

63. Hms3712a08

64. Hms3886d07

65. Pharmakon1600-02300219

66. Benzenaminium, N-ethyl-3-hydroxy-n,n-dimethyl-, Chloride (1:1)

67. Hy-b0882

68. Edrophonium Chloride [vandf]

69. Tox21_110138

70. Tox21_500511

71. Ccg-39644

72. Edrophonium Chloride [mart.]

73. Mfcd00055064

74. Nsc759577

75. Edrophonium Chloride [usp-rs]

76. Edrophonium Chloride [who-dd]

77. Edrophonium Chloride [who-ip]

78. Akos015890417

79. Tox21_110138_1

80. Cs-4337

81. Ds-0552

82. Edrophonium Chloride (jp17/usp/inn)

83. Lp00511

84. Nc00561

85. Nsc 759577

86. Ncgc00015409-11

87. Ncgc00093908-01

88. Ncgc00093908-02

89. Ncgc00093908-03

90. Ncgc00093908-04

91. Ncgc00093908-05

92. Ncgc00261196-01

93. Edrophonium Chloride [orange Book]

94. Edrophonium Chloride [ep Monograph]

95. Edrophonii Chloridum [who-ip Latin]

96. Edrophonium Chloride [usp Monograph]

97. Eu-0100511

98. Ft-0657849

99. D00994

100. E 3256

101. Enlon-plus Component Edrophonium Chloride

102. Ethyl-(3-hydroxyphenyl)-dimethylammonium Chloride

103. A803607

104. Ethyl-(3-hydroxyphenyl)-dimethyl-azanium Chloride

105. Edrophonium Chloride Component Of Enlon-plus

106. J-003433

107. Sr-01000000275-2

108. Sr-01000000275-4

109. Sr-01000000275-6

110. N-ethyl-3-hydroxy-n,n-dimethyl-benzenaminium Chloride

111. Q27068168

112. Edrophonium Chloride, Europepharmacopoeia (ep) Reference Standard

113. Edrophonium Chloride, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date
2005-03-27
3 Chemical and Physical Properties
Molecular Weight 201.69 g/mol
Molecular Formula C10H16ClNO
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count2
Exact Mass201.0920418 g/mol
Monoisotopic Mass201.0920418 g/mol
Topological Polar Surface Area20.2 Ų
Heavy Atom Count13
Formal Charge0
Complexity145
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 2  
Drug NameTensilon preservative free
Active IngredientEdrophonium chloride
Dosage FormInjectable
RouteInjection
Strength10mg/ml
Market StatusPrescription
CompanyValeant Pharms

2 of 2  
Drug NameTensilon preservative free
Active IngredientEdrophonium chloride
Dosage FormInjectable
RouteInjection
Strength10mg/ml
Market StatusPrescription
CompanyValeant Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Cholinesterase Inhibitors

Drugs that inhibit cholinesterases. The neurotransmitter ACETYLCHOLINE is rapidly hydrolyzed, and thereby inactivated, by cholinesterases. When cholinesterases are inhibited, the action of endogenously released acetylcholine at cholinergic synapses is potentiated. Cholinesterase inhibitors are widely used clinically for their potentiation of cholinergic inputs to the gastrointestinal tract and urinary bladder, the eye, and skeletal muscles; they are also used for their effects on the heart and the central nervous system. (See all compounds classified as Cholinesterase Inhibitors.)


Antidotes

Agents counteracting or neutralizing the action of POISONS. (See all compounds classified as Antidotes.)


USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6099

Submission : 1985-11-19

Status : Active

Type : II

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Nv Organon

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Nv Organon

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5649

Submission : 1984-12-17

Status : Inactive

Type : II

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Medea Research Laboratories Inc

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Medea Research Laboratories Inc

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DMF Review : N/A

Rev. Date :

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DMF Number : 7465

Submission : 1988-05-03

Status : Inactive

Type : II

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Anaquest Div Boc Inc

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6747

Submission : 1986-12-29

Status : Inactive

Type : II

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Actavis Inc

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EDROPHONIUM CHLORIDE

Brand Name : EDROPHONIUM CHLORIDE PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Packaging :

Approval Date : 1996-03-20

Application Number : 40043

Regulatory Info : DISCN

Registration Country : USA

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Farbe Firma

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Edrophonium Chloride; Atropine

Brand Name :

Dosage Form : Injection

Dosage Strength : 10MG/ML; 0.14MG/ML

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Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Edrophonium Chloride; Atropine

Brand Name :

Dosage Form : Injection

Dosage Strength : 10MG/ML; 0.14MG/ML

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Approval Date :

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Registration Country : India

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Farbe Firma

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Edrophonium Chloride; Atropine

Brand Name :

Dosage Form : Injection

Dosage Strength : 10MG/ML; 0.14MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Farbe Firma

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Edrophonium Chloride

Brand Name :

Dosage Form : Injection

Dosage Strength : 10MG/ML

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Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Farbe Firma

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Dosage Form : Injection

Dosage Strength : 10MG/ML; 0.14MG/ML

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Registration Country : India

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Farbe Firma

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Dosage Form : Injection

Dosage Strength : 10MG/ML

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Registration Country : India

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EDROPHONIUM CHLORIDE

Brand Name : EDROPHONIUM CHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Packaging :

Approval Date : 1998-02-24

Application Number : 40131

Regulatory Info : DISCN

Registration Country : USA

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Merck & Co

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EDROPHONIUM CHLORIDE

Brand Name : REVERSOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Packaging :

Approval Date : 1988-05-13

Application Number : 89624

Regulatory Info : DISCN

Registration Country : USA

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EDROPHONIUM CHLORIDE

Brand Name : TENSILON PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 1982-01-01

Application Number : 7959

Regulatory Info : DISCN

Registration Country : USA

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Brand Name : EDROPHONIUM CHLORIDE PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1996-03-20

Application Number : 40043

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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EDROPHONIUM CHLORIDE

Brand Name : EDROPHONIUM CHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1996-03-20

Application Number : 40044

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Brand Name : EDROPHONIUM CHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1998-02-24

Application Number : 40131

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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EDROPHONIUM CHLORIDE

Brand Name : REVERSOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1988-05-13

Application Number : 89624

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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EDROPHONIUM CHLORIDE

Brand Name : TENSILON

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 7959

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Brand Name : TENSILON PRESERVATIVE FREE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 7959

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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ATROPINE SULFATE; EDROPHONIUM CHLORIDE

Brand Name : ENLON-PLUS

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.14MG/ML;10MG/ML

Approval Date : 1991-11-06

Application Number : 19677

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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ATROPINE SULFATE; EDROPHONIUM CHLORIDE

Brand Name : ENLON-PLUS

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.14MG/ML;10MG/ML

Approval Date : 1991-11-06

Application Number : 19678

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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EDROPHONIUM CHLORIDE

Brand Name : ENLON

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1985-08-06

Application Number : 88873

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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ABOUT THIS PAGE

Edrophonium Chloride Manufacturers

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

Edrophonium Chloride Suppliers

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

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

Edrophonium Chloride USDMF

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

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

click here to find a list of Edrophonium Chloride suppliers with USDMF on PharmaCompass.

Edrophonium Chloride 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 Edrophonium Chloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Edrophonium Chloride GMP

Edrophonium Chloride 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 Edrophonium Chloride 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 Edrophonium Chloride GMP manufacturer or Edrophonium Chloride GMP API supplier for your needs.

Edrophonium Chloride CoA

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

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

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