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Chemistry

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Also known as: 138786-67-1, Pantoloc, Protonix, Pantecta, Zurcal, Pantoprazole sodium salt
Molecular Formula
C16H14F2N3NaO4S
Molecular Weight
405.4  g/mol
InChI Key
YNWDKZIIWCEDEE-UHFFFAOYSA-N

Pantoprazole Sodium
2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.
1 2D Structure

Pantoprazole Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
2.1.2 InChI
InChI=1S/C16H14F2N3O4S.Na/c1-23-13-5-6-19-12(14(13)24-2)8-26(22)16-20-10-4-3-9(25-15(17)18)7-11(10)21-16;/h3-7,15H,8H2,1-2H3;/q-1;+1
2.1.3 InChI Key
YNWDKZIIWCEDEE-UHFFFAOYSA-N
2.1.4 Canonical SMILES
COC1=C(C(=NC=C1)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC(F)F)OC.[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. By 1023

2. By-1023

3. By1023

4. Pantoprazole

5. Protonix

6. Sk And F 96022

7. Sk And F-96022

8. Sk And F96022

9. Skf 96022

10. Skf-96022

11. Skf96022

2.2.2 Depositor-Supplied Synonyms

1. 138786-67-1

2. Pantoloc

3. Protonix

4. Pantecta

5. Zurcal

6. Pantoprazole Sodium Salt

7. Skf96022 Sodium

8. By-1023 Sodium

9. Chebi:50270

10. Sodium;5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

11. Pantozol Control

12. 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl) Sulfinyl)-1h-benzimidazole Sodium

13. Dsstox_cid_24215

14. Dsstox_rid_80123

15. Dsstox_gsid_44215

16. Sodium 5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide

17. Sodium 5-(difluoromethoxy)-2-((3,4-dimethoxypyridin-2-yl)methylsulfinyl)benzo[d]imidazol-1-ide

18. Cas-138786-67-1

19. Anagastra

20. Inipomp

21. Pantorc

22. Peptazol

23. Ulcotenal

24. Citrel

25. Apton

26. Rifun

27. Pantoprazole Sodium;

28. By1023 (sodium)

29. Pantoprazole Sodium,(s)

30. Skf96022 (sodium)

31. Schembl3543

32. Mls001424073

33. Pantoprazole Sodium Monohydrate

34. Chembl1200408

35. Dtxsid7044215

36. Dz-2352a

37. Hms2051l19

38. Hms3393l19

39. Hms3715d12

40. Act02633

41. Tox21_112996

42. Tox21_302362

43. Mfcd01658543

44. S4538

45. Akos015994677

46. Ccg-100980

47. Ks-1093

48. Nc00230

49. S86p671

50. Sb17369

51. By-1023/sk&f-96022

52. Ncgc00255835-01

53. Smr000469592

54. Ft-0602602

55. Ft-0673508

56. A807440

57. B-8610-23/sk&f-96022-z

58. J-516336

59. B-8510-29

60. Q27122012

61. Sodium 5-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl] Benzimidazol-1-ide

62. 5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole, Sodium Salt

63. 5-(difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridyl)methylsulfinyl]benzimidazol-1-ide; Sodium;pantoprazole Sodium

64. Sodium 5-(difluoromethoxy)-2-(((3,4-dimethoxy-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

65. Sodium 5-(difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide

2.2.3 Other Synonyms

1. Pantozol

2. S-pantoprazole

3. Pantoprazole

2.3 Create Date
2007-02-09
3 Chemical and Physical Properties
Molecular Weight 405.4 g/mol
Molecular Formula C16H14F2N3NaO4S
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count10
Rotatable Bond Count7
Exact Mass405.05707772 g/mol
Monoisotopic Mass405.05707772 g/mol
Topological Polar Surface Area90.8 Ų
Heavy Atom Count27
Formal Charge0
Complexity497
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
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 NamePantoprazole sodium
Drug LabelThe active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid...
Active IngredientPantoprazole sodium
Dosage FormInjectable; Tablet, delayed release
Routeinjection; Iv (infusion); Oral
Strengtheq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Mylan Pharms; Hetero Labs Ltd V; Teva Parenteral; Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Sun Pharma Global; Perrigo R And D; Actavis Elizabeth; Macleods Pharms; Jubilant Generics; Kudco Ireland; Ranbaxy Labs; Dr Reddys Labs; Akorn

2 of 4  
Drug NameProtonix iv
Active IngredientPantoprazole sodium
Dosage FormInjectable
RouteIv (infusion)
Strengtheq 40mg base/vial
Market StatusPrescription
CompanyWyeth Pharms

3 of 4  
Drug NamePantoprazole sodium
Drug LabelThe active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid...
Active IngredientPantoprazole sodium
Dosage FormInjectable; Tablet, delayed release
Routeinjection; Iv (infusion); Oral
Strengtheq 20mg base; eq 40mg base/vial; eq 40mg base; 40mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Mylan Pharms; Hetero Labs Ltd V; Teva Parenteral; Teva; Apotex; Aurobindo Pharma; Torrent Pharms; Sun Pharma Global; Perrigo R And D; Actavis Elizabeth; Macleods Pharms; Jubilant Generics; Kudco Ireland; Ranbaxy Labs; Dr Reddys Labs; Akorn

4 of 4  
Drug NameProtonix iv
Active IngredientPantoprazole sodium
Dosage FormInjectable
RouteIv (infusion)
Strengtheq 40mg base/vial
Market StatusPrescription
CompanyWyeth Pharms

4.2 Drug Indication

Short-term treatment of reflux symptoms (e. g. heartburn, acid regurgitation) in adults.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)


Proton Pump Inhibitors

Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Proton Pump Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
5.3 ATC Code

A02BC02


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01-Jan-2022
31-Jul-2025
KGS
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DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 40MG BASE/VIAL

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ABOUT THIS PAGE

Looking for 138786-67-1 / Pantoprazole Sodium API manufacturers, exporters & distributors?

Pantoprazole Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pantoprazole Sodium

Synonyms

138786-67-1, Pantoloc, Protonix, Pantecta, Zurcal, Pantoprazole sodium salt

Cas Number

138786-67-1

About Pantoprazole Sodium

2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.

Pantozol Manufacturers

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

Pantozol Suppliers

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

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

Pantozol USDMF

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

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

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

Pantozol KDMF

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

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

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

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

Pantozol CEP

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

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

Pantozol WC

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

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

Pantozol 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 Pantozol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pantozol GMP

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

Pantozol CoA

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

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

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