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Chemistry

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Also known as: 130693-82-2, Dorzolamide hcl, Trusopt, Dorzolomide hydrochloride, Cosopt, Dorzolamide (hydrochloride)
Molecular Formula
C10H17ClN2O4S3
Molecular Weight
360.9  g/mol
InChI Key
OSRUSFPMRGDLAG-QMGYSKNISA-N
FDA UNII
QZO5366EW7

Dorzolamide Hydrochloride
Dorzolamide Hydrochloride is the hydrochloride salt form of dorzolamide, an inhibitor of carbonic anhydrase, a zinc-containing enzyme that catalyzes the rapid conversion of carbon dioxide and water into carbonic acid, protons and bicarbonate ions. Distributed throughout many cells and tissues, various carbonic anhydrases play important roles in mineral and metabolic homeostasis. (NCI04)
1 2D Structure

Dorzolamide Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S,6S)-4-(ethylamino)-6-methyl-7,7-dioxo-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide;hydrochloride
2.1.2 InChI
InChI=1S/C10H16N2O4S3.ClH/c1-3-12-8-4-6(2)18(13,14)10-7(8)5-9(17-10)19(11,15)16;/h5-6,8,12H,3-4H2,1-2H3,(H2,11,15,16);1H/t6-,8-;/m0./s1
2.1.3 InChI Key
OSRUSFPMRGDLAG-QMGYSKNISA-N
2.1.4 Canonical SMILES
CCNC1CC(S(=O)(=O)C2=C1C=C(S2)S(=O)(=O)N)C.Cl
2.1.5 Isomeric SMILES
CCN[C@H]1C[C@@H](S(=O)(=O)C2=C1C=C(S2)S(=O)(=O)N)C.Cl
2.2 Other Identifiers
2.2.1 UNII
QZO5366EW7
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-ethylamino-5,6-dihydro-6-methyl-7,7-dioxide-4h-thieno(2,3-b)thiopyran-2-sulfonamide

2. 5,6-dihydro-4-ethylamino-6-methyl-4h-thieno(2,3-b)thiopyran-2-sulfonamide-7,7-dioxide

3. Dorzolamide

4. Dorzolamide Chibret

5. Dorzolamide, (trans)-isomer

6. L 671152

7. L-671,152

8. Mk 507

9. Mk-507

10. Trusopt

2.3.2 Depositor-Supplied Synonyms

1. 130693-82-2

2. Dorzolamide Hcl

3. Trusopt

4. Dorzolomide Hydrochloride

5. Cosopt

6. Dorzolamide (hydrochloride)

7. Mk-507

8. Dorzolomide Hcl

9. (4s,6s)-4-(ethylamino)-6-methyl-5,6-dihydro-4h-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide Hydrochloride

10. Dorzolamide (as Hydrochloride)

11. Qzo5366ew7

12. Trusopt (tn)

13. Dsstox_cid_25530

14. Dsstox_rid_80933

15. Dsstox_gsid_45530

16. (4s,6s)-4-(ethylamino)-5,6-dihydro-6-methyl-4h-thieno(2,3-b)thiopyran-2-sulfonamide 7,7-dioxide, Monohydrochloride

17. Chebi:4703

18. (4s,6s)-4-(ethylamino)-6-methyl-7,7-dioxo-5,6-dihydro-4h-thieno[2,3-b]thiopyran-2-sulfonamide;hydrochloride

19. 4h-thieno(2,3-b)thiopyran-2-sulfonamide, 4-(ethylamino)-5,6-dihydro-6-methyl-, 7,7-dioxide, Monohydrochloride, (4s-trans)-

20. Unii-qzo5366ew7

21. Sr-05000001449

22. Dorzolamide Hydrochloride [usan]

23. L 671152

24. L-671,152

25. Dorzolamide Hcl Salt

26. Dorzolamide Hydrochloride [usan:usp]

27. Mk507 Hydrochloride

28. Mk 0507

29. Mk-0507

30. L671152 Hydrochloride

31. Ncgc00016977-01

32. Cas-130693-82-2

33. Schembl41152

34. Mls002154162

35. Chembl1201162

36. Dtxsid1045530

37. Dorzolamide Hydrochloride- Bio-x

38. Hy-b0109a

39. Hms1571o14

40. Ex-a3987

41. Tox21_110720

42. Mfcd00884659

43. S1375

44. Dorzolamide Hydrochloride [mi]

45. Akos005146235

46. Akos015895951

47. Dorzolamide Hydrochloride (jp17/usp)

48. Tox21_110720_1

49. Ac-5244

50. Ccg-221116

51. Cs-1858

52. Dorzolamide Hydrochloride [jan]

53. Ks-1348

54. Dorzolamide Hydrochloride [mart.]

55. Dorzolamide Hydrochloride [vandf]

56. Ncgc00179244-03

57. Bd164381

58. Dorzolamide Hydrochloride [usp-rs]

59. Dorzolamide Hydrochloride [who-dd]

60. Smr001233461

61. Mk-507 (l-671152) Hcl

62. D4189

63. Dorzolamide Hydrochloride, Trans-(-)-

64. C72221

65. D00653

66. Dorzolamide Hydrochloride [orange Book]

67. Dorzolamide Hydrochloride [usp Impurity]

68. Cosopt Component Dorzolamide Hydrochloride

69. Dorzolamide Hydrochloride [usp Monograph]

70. 279d961

71. Dorzolamide Hydrochloride Component Of Cosopt

72. L-671152

73. Sr-05000001449-3

74. Q27106441

75. Dorzolamide Hydrochloride, European Pharmacopoeia (ep) Reference Standard

76. Dorzolamide For System Suitability, European Pharmacopoeia (ep) Reference Standard

77. Dorzolamide Hydrochloride, United States Pharmacopeia (usp) Reference Standard

78. (4s,6s)-4-(ethylamino)-5,6-dihydro-6-methyl-, 7,7-dioxide 4h-thieno[2,3-b]thiopyran-2-sulfonamide Hydrochloride

79. 122028-16-4

80. 4h-thieno(2,3-b)thiopyran-2-sulfonamide, 5,6-dihydro-4-(ethylamino)-6-methyl-, 7,7-dioxide, Monohydrochloride, (4s,6s)-

2.4 Create Date
2006-07-28
3 Chemical and Physical Properties
Molecular Weight 360.9 g/mol
Molecular Formula C10H17ClN2O4S3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count3
Exact Mass360.0038982 g/mol
Monoisotopic Mass360.0038982 g/mol
Topological Polar Surface Area151 Ų
Heavy Atom Count20
Formal Charge0
Complexity534
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 NameCosopt
PubMed HealthDorzolamide/Timolol (Into the eye)
Drug ClassesAntiglaucoma, Beta-Adrenergic Blocker/Carbonic Anhydrase Inhibitor Combination
Active IngredientDorzolamide hydrochloride; timolol maleate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.5% base; eq 2% base
Market StatusPrescription
CompanyOak Pharms Akorn

2 of 4  
Drug NameDorzolamide hydrochloride
Drug LabelDorzolamide Hydrochloride Ophthalmic Solution USP, 2% is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.Dorzolamide hydrochloride, USP is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]th...
Active IngredientDorzolamide hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 2% base
Market StatusPrescription
CompanyWatson Labs; Zach Systems; Teva Pharms; Hi Tech Pharma; Bausch And Lomb; Alcon Pharms; Luitpold; Sandoz

3 of 4  
Drug NameCosopt
PubMed HealthDorzolamide/Timolol (Into the eye)
Drug ClassesAntiglaucoma, Beta-Adrenergic Blocker/Carbonic Anhydrase Inhibitor Combination
Active IngredientDorzolamide hydrochloride; timolol maleate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.5% base; eq 2% base
Market StatusPrescription
CompanyOak Pharms Akorn

4 of 4  
Drug NameDorzolamide hydrochloride
Drug LabelDorzolamide Hydrochloride Ophthalmic Solution USP, 2% is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.Dorzolamide hydrochloride, USP is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]th...
Active IngredientDorzolamide hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 2% base
Market StatusPrescription
CompanyWatson Labs; Zach Systems; Teva Pharms; Hi Tech Pharma; Bausch And Lomb; Alcon Pharms; Luitpold; Sandoz

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


Carbonic Anhydrase Inhibitors

A class of compounds that reduces the secretion of H+ ions by the proximal kidney tubule through inhibition of CARBONIC ANHYDRASES. (See all compounds classified as Carbonic Anhydrase Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Carbonic Anhydrase Inhibitors [MoA]; Carbonic Anhydrase Inhibitor [EPC]

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01-Jan-2021
28-Feb-2025
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BA...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20408

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BA...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE;EQ 0.5% BASE

USFDA APPLICATION NUMBER - 20869

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ABOUT THIS PAGE

Looking for 122028-16-4 / Dorzolamide Hydrochloride API manufacturers, exporters & distributors?

Dorzolamide Hydrochloride manufacturers, exporters & distributors 1

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

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

API | Excipient name

Dorzolamide Hydrochloride

Synonyms

130693-82-2, Dorzolamide hcl, Trusopt, Dorzolomide hydrochloride, Cosopt, Dorzolamide (hydrochloride)

Cas Number

122028-16-4

Unique Ingredient Identifier (UNII)

QZO5366EW7

About Dorzolamide Hydrochloride

Dorzolamide Hydrochloride is the hydrochloride salt form of dorzolamide, an inhibitor of carbonic anhydrase, a zinc-containing enzyme that catalyzes the rapid conversion of carbon dioxide and water into carbonic acid, protons and bicarbonate ions. Distributed throughout many cells and tissues, various carbonic anhydrases play important roles in mineral and metabolic homeostasis. (NCI04)

Dorzolamide HCl Manufacturers

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

Dorzolamide HCl Suppliers

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

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

Dorzolamide HCl USDMF

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

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

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

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

Dorzolamide HCl KDMF

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

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

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

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

Dorzolamide HCl CEP

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

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

Dorzolamide HCl WC

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

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

Dorzolamide HCl 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 Dorzolamide HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Dorzolamide HCl GMP

Dorzolamide HCl 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 Dorzolamide HCl 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 Dorzolamide HCl GMP manufacturer or Dorzolamide HCl GMP API supplier for your needs.

Dorzolamide HCl CoA

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

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

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