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7EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 65899-73-2, Vagistat, Vagistat-1, Trosyd, Trosyl, Gyno-trosyd
Molecular Formula
C16H13Cl3N2OS
Molecular Weight
387.7  g/mol
InChI Key
QXHHHPZILQDDPS-UHFFFAOYSA-N
FDA UNII
S57Y5X1117

Tioconazole
Tioconazole is a synthetic imidazole derivative, fungicidal Terconazole inhibits cell wall synthesis by inhibiting the biosynthesis of ergosterol or other sterols, damaging the fungal cell membrane, altering its permeability, and promoting loss of essential intracellular elements. Tioconazole is active against pathogenic Candida. (NCI04)
Tioconazole is an Azole Antifungal.
1 2D Structure

Tioconazole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[2-[(2-chlorothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole
2.1.2 InChI
InChI=1S/C16H13Cl3N2OS/c17-12-1-2-13(14(18)7-12)15(8-21-5-4-20-10-21)22-9-11-3-6-23-16(11)19/h1-7,10,15H,8-9H2
2.1.3 InChI Key
QXHHHPZILQDDPS-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC(=C(C=C1Cl)Cl)C(CN2C=CN=C2)OCC3=C(SC=C3)Cl
2.2 Other Identifiers
2.2.1 UNII
S57Y5X1117
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Gyno-trosyd

2. Monistat 1-day

3. Mykontral

4. Trosderm

5. Trosid

6. Trosyd

7. Trosyl

8. Uk 20,349

9. Vagistat

10. Vagistat-1

2.3.2 Depositor-Supplied Synonyms

1. 65899-73-2

2. Vagistat

3. Vagistat-1

4. Trosyd

5. Trosyl

6. Gyno-trosyd

7. Fungibacid

8. Zoniden

9. Tioconazol [inn-spanish]

10. Tioconazolum [inn-latin]

11. Uk-20349

12. 1-(2-((2-chlorothiophen-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole

13. Uk-20,349

14. Tioconazolum

15. Nsc-759169

16. 1-[2-[(2-chlorothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole

17. Tioconazol

18. Chebi:77898

19. Mfcd00057276

20. S57y5x1117

21. Ncgc00167430-01

22. Tz-3

23. 1-{2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl}imidazole

24. 1-{2-[(2-chlorothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl}-1h-imidazole

25. 1h-imidazole, 1-(2-((2-chloro-3-thienyl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-

26. Dsstox_cid_26619

27. Dsstox_rid_81771

28. Dsstox_gsid_46619

29. New Straitus

30. 1-[2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole

31. Smr001550005

32. (+-)-tioconazole

33. Cas-65899-73-2

34. Vagistat-1 (tn)

35. Uk 20349

36. Sr-05000001939

37. Einecs 265-973-8

38. Brn 0573867

39. Tioconazole (jan/usp/inn)

40. Unii-s57y5x1117

41. 1h-imidazole, 1-[2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-

42. 1-[(2s)-2-[(2-chlorothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole

43. 1-(2,4-dichloro-beta-((2-chloro-3-thenyl)-oxy)phenethyl)imidazole

44. (+-)-1-(2,4-dichloro-beta-((2-chloro-3-ethenyl)oxy)phenethyl)imidazole

45. Tioconazole, 97%

46. Tioconazole [usan:usp:inn:ban:jan]

47. Tioconazole [mi]

48. 1-(2,4-dichloro-(beta-(2-chloro-3-thenyl)oxy)phenethyl)imidazole

49. Tioconazole [inn]

50. Tioconazole [jan]

51. (.+/-.)-tioconazole

52. Tioconazole [inci]

53. Tioconazole [usan]

54. Tioconazole [vandf]

55. Tioconazole [mart.]

56. Schembl41354

57. Tioconazole [usp-rs]

58. Tioconazole [who-dd]

59. 5-23-04-00324 (beilstein Handbook Reference)

60. Mls003899209

61. Mls004712040

62. Mls006010907

63. Chembl1200438

64. Dtxsid3046619

65. Tioconazole [orange Book]

66. Tioconazole For System Suitability

67. Hms2090b12

68. Hms2093p11

69. Hms3655k22

70. Hms3712i10

71. Pharmakon1600-01505581

72. Tioconazole [ep Monograph]

73. Tioconazole [usp Impurity]

74. Tioconazole [usp Monograph]

75. Amy32535

76. Hy-b0319

77. Tox21_112434

78. Bdbm50370218

79. Dl-515

80. Nsc759169

81. S1910

82. Akos015906500

83. Tox21_112434_1

84. Ccg-213487

85. Db01007

86. Ks-5114

87. Nsc 759169

88. (+-)-1-[2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole

89. Ncgc00167430-02

90. Ncgc00167430-03

91. Ncgc00167430-04

92. Ac-13425

93. Ac-31721

94. Sbi-0206824.p001

95. Ft-0630756

96. Sw198590-2

97. C08082

98. D00890

99. D83125

100. Ab01275523-01

101. Ab01275523_02

102. Ab01275523_03

103. Tioconazole, Vetranal(tm), Analytical Standard

104. 899t732

105. A835270

106. Q260326

107. Sr-05000001939-1

108. Sr-05000001939-2

109. Brd-a33084557-001-01-7

110. Tioconazole, United States Pharmacopeia (usp) Reference Standard

111. 1-[2,4-dichloro-.beta.-[(2-chloro-3-thenyl)-oxy]phenethyl]imidazole

112. (.+/-.)-1-(2,4-dichloro-.beta.-((2-chloro-3-ethenyl)oxy)phenethyl)imidazole

113. 1-[2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole #

114. 1-{2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl}-1h-imidazole

115. Tioconazole For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 387.7 g/mol
Molecular Formula C16H13Cl3N2OS
XLogP35.3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count3
Rotatable Bond Count6
Exact Mass385.981417 g/mol
Monoisotopic Mass385.981417 g/mol
Topological Polar Surface Area55.3 Ų
Heavy Atom Count23
Formal Charge0
Complexity379
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameTioconazole
PubMed HealthTioconazole (Topical route)
Drug ClassesImidazole
Active IngredientTioconazole
Dosage FormOintment
RouteVaginal
Strength6.5%
Market StatusOver the Counter
CompanyPerrigo

2 of 4  
Drug NameVagistat-1
Active IngredientTioconazole
Dosage FormOintment
RouteVaginal
Strength6.5%
Market StatusOver the Counter
CompanyNovartis

3 of 4  
Drug NameTioconazole
PubMed HealthTioconazole (Topical route)
Drug ClassesImidazole
Active IngredientTioconazole
Dosage FormOintment
RouteVaginal
Strength6.5%
Market StatusOver the Counter
CompanyPerrigo

4 of 4  
Drug NameVagistat-1
Active IngredientTioconazole
Dosage FormOintment
RouteVaginal
Strength6.5%
Market StatusOver the Counter
CompanyNovartis

4.2 Drug Indication

For the local treatment of vulvovaginal candidiasis (moniliasis).


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Tioconazole is a broad-spectrum imidazole antifungal agent that inhibits the growth of human pathogenic yeasts. Tioconazole exhibits fungicidal activity in vitro against Candida albicans, other species of the genus Candida, and against Torulopsis glabrata. Tioconazole prevents the growth and function of some fungal organisms by interfering with the production of substances needed to preserve the cell membrane. This drug is effective only for infections caused by fungal organisms. It will not work for bacterial or viral infections.


5.2 MeSH Pharmacological Classification

14-alpha Demethylase Inhibitors

Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)


Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
TIOCONAZOLE
5.3.2 FDA UNII
S57Y5X1117
5.3.3 Pharmacological Classes
Azoles [CS]; Azole Antifungal [EPC]
5.4 ATC Code

D - Dermatologicals

D01 - Antifungals for dermatological use

D01A - Antifungals for topical use

D01AC - Imidazole and triazole derivatives

D01AC07 - Tioconazole


G - Genito urinary system and sex hormones

G01 - Gynecological antiinfectives and antiseptics

G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

G01AF - Imidazole derivatives

G01AF08 - Tioconazole


5.5 Absorption, Distribution and Excretion

Absorption

Systemic absorption following a single intravaginal application of tioconazole in nonpregnant patients is negligible.


5.6 Metabolism/Metabolites

Orally administered tioconazole is extensively metabolized. The major metabolites are glucuronide conjugates.


5.7 Mechanism of Action

Tioconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability. Tioconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms and the uptake of purine, impair triglyceride and/or phospholipid biosynthesis, and inhibit the movement of calcium and potassium ions across the cell membrane by blocking the ion transport pathway known as the Gardos channel.


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22-Jan-2021
25-Nov-2024
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ABOUT THIS PAGE

Tioconazole Manufacturers

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

Tioconazole Suppliers

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

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

Tioconazole USDMF

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

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

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

Tioconazole CEP

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

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

Tioconazole WC

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

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

Tioconazole 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 Tioconazole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tioconazole GMP

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

Tioconazole CoA

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

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

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