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Chemistry

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Also known as: 117976-90-6, Rebeprazole sodium, Pariet, Aciphex, Rabeprazole sodium salt, Dexrabeprazole sodium
Molecular Formula
C18H20N3NaO3S
Molecular Weight
381.4  g/mol
InChI Key
KRCQSTCYZUOBHN-UHFFFAOYSA-N
FDA UNII
3L36P16U4R

Rabeprazole Sodium
A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
1 2D Structure

Rabeprazole Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]benzimidazol-1-ide
2.1.2 InChI
InChI=1S/C18H20N3O3S.Na/c1-13-16(19-9-8-17(13)24-11-5-10-23-2)12-25(22)18-20-14-6-3-4-7-15(14)21-18;/h3-4,6-9H,5,10-12H2,1-2H3;/q-1;+1
2.1.3 InChI Key
KRCQSTCYZUOBHN-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C=CN=C1CS(=O)C2=NC3=CC=CC=C3[N-]2)OCCCOC.[Na+]
2.2 Other Identifiers
2.2.1 UNII
3L36P16U4R
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1h-benzimidazole, 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt

2. 2-((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methylsulfinyl)-1h-benzimidazole

3. Aciphex

4. Dexrabeprazole

5. E 3810

6. E3810

7. Ly 307640

8. Ly-307640

9. Ly307640

10. Pariet

11. Rabeprazole

12. Sodium, Rabeprazole

2.3.2 Depositor-Supplied Synonyms

1. 117976-90-6

2. Rebeprazole Sodium

3. Pariet

4. Aciphex

5. Rabeprazole Sodium Salt

6. Dexrabeprazole Sodium

7. Rabeprazole (sodium)

8. (s)-rabeprazole Sodium Salt

9. Aciphex Sprinkle

10. Ly307640 Sodium

11. Sodium Rabeprazole

12. Rabeprazole Sodium [usan]

13. Idiazole

14. Rabeprazole Na

15. Chebi:8769

16. 171440-19-0

17. Ly-307640

18. E3810

19. E-3810 Sodium

20. Sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]benzimidazol-1-ide

21. Ly-307640 Sodium

22. 3l36p16u4r

23. 1h-benzimidazole, 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt

24. 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridyl)methyl)sulfinyl)benzimidazole Sodium Salt

25. Nsc-759270

26. Dsstox_cid_24205

27. Dsstox_rid_80118

28. Dsstox_gsid_44205

29. 1h-benzimidazole, 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-, Sodium Salt (1:1)

30. Rabicip

31. Pepcia

32. Aciphex Sodium

33. Ly 307640 Sodium

34. Habeprazole Sodium

35. Sodium 2-((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methylsulfinyl)benzo[d]imidazol-1-ide

36. Sodium 2-({[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methyl}sulfinyl)benzimidazol-1-ide

37. Smr000550493

38. Cas-117976-90-6

39. Ncgc00159518-02

40. E 3810

41. Pariete

42. Unii-3l36p16u4r

43. Pariprazole Sodium

44. Dexrabeprazolesodium

45. Rebeprazole Sodium;

46. Aciphex (tn)

47. Pariet (tn)

48. Rebeprazole Sodium Salt

49. Rabeprazole Sodium- Bio-x

50. Mls001165734

51. Mls006010621

52. Schembl140494

53. Rabeprazole Na [vandf]

54. Chembl1200930

55. Dtxsid3044205

56. Rabeprazole Sodium [jan]

57. Hy-b0656a

58. Rabeprazole Sodium (jp17/usp)

59. Ex-a176

60. Hms2093h10

61. Hms2231e04

62. Hms3373b05

63. Rabeprazole Sodium [mart.]

64. Bcp06639

65. Rabeprazole Sodium [usp-rs]

66. Rabeprazole Sodium [who-dd]

67. Tox21_111736

68. Tox21_302317

69. Ac-715

70. Bdbm50247881

71. Mfcd02092688

72. Rabeprazole Sodium Salt [mi]

73. S4665

74. Rabeprazole Sodium, >=98% (hplc)

75. Akos015895734

76. Akos015962116

77. Akos025310160

78. Tox21_111736_1

79. Am81231

80. Ccg-213574

81. Ccg-268423

82. Nsc 759270

83. Rabeprazole Sodium [orange Book]

84. Ncgc00159518-05

85. Ncgc00255838-01

86. Rabeprazole Sodium [ep Monograph]

87. As-13338

88. Br167318

89. Rabeprazole Sodium [usp Monograph]

90. Ft-0631090

91. Ft-0689461

92. R0115

93. C07865

94. D00724

95. F17418

96. 976r906

97. Sr-01000799133

98. J-010726

99. Q-201655

100. Sr-01000799133-2

101. Q27108142

102. [2-[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methylsulfinyl]benzimidazol-1-yl]sodium

103. Sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]-1h-benzimidazole

104. 1h-benzimidazole,2-[[[4-(3-methoxypropoxy)- 3-methyl-2-pyridinyl]methyl]sulfinyl]-,sodium Salt

105. 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole, Sodium Salt

106. Sodium 2-(((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide

2.4 Create Date
2007-02-09
3 Chemical and Physical Properties
Molecular Weight 381.4 g/mol
Molecular Formula C18H20N3NaO3S
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count7
Rotatable Bond Count8
Exact Mass381.11230696 g/mol
Monoisotopic Mass381.11230696 g/mol
Topological Polar Surface Area81.5 Ų
Heavy Atom Count26
Formal Charge0
Complexity446
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 NameAciphex
PubMed HealthRabeprazole (By mouth)
Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active IngredientRabeprazole sodium
Dosage FormTablet, delayed release
Routeoral; Oral
Strength20mg
Market StatusPrescription
CompanyEisai; Eisai Medcl Res

2 of 4  
Drug NameRabeprazole sodium
Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active IngredientRabeprazole sodium
Dosage FormTablet, delayed release
RouteOral
Strength20mg
Market StatusPrescription
CompanyMylan Pharms; Kremers Urban Dev; Teva Pharms Usa; Torrent Pharms; Lupin; Dr Reddys Labs

3 of 4  
Drug NameAciphex
PubMed HealthRabeprazole (By mouth)
Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active IngredientRabeprazole sodium
Dosage FormTablet, delayed release
Routeoral; Oral
Strength20mg
Market StatusPrescription
CompanyEisai; Eisai Medcl Res

4 of 4  
Drug NameRabeprazole sodium
Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
Active IngredientRabeprazole sodium
Dosage FormTablet, delayed release
RouteOral
Strength20mg
Market StatusPrescription
CompanyMylan Pharms; Kremers Urban Dev; Teva Pharms Usa; Torrent Pharms; Lupin; Dr Reddys Labs

4.2 Drug Indication

Treatment of duodenal ulcer, Treatment of gastric ulcer, Treatment of gastro-oesophageal reflux disease, Treatment of Helicobacter pylori in patients with peptic ulcer disease, Treatment of Zollinger-Ellison syndrome


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]

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03-Jan-2022
30-Apr-2025
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 204736

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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 5MG

USFDA APPLICATION NUMBER - 204736

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG ...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20973

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - 20MG

USFDA APPLICATION NUMBER - 20973

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ABOUT THIS PAGE

Looking for 117976-90-6 / Rabeprazole API manufacturers, exporters & distributors?

Rabeprazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rabeprazole

Synonyms

117976-90-6, Rebeprazole sodium, Pariet, Aciphex, Rabeprazole sodium salt, Dexrabeprazole sodium

Cas Number

117976-90-6

Unique Ingredient Identifier (UNII)

3L36P16U4R

About Rabeprazole

A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.

Aciphex Manufacturers

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

Aciphex Suppliers

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

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

Aciphex USDMF

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

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

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

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

Aciphex KDMF

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

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

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

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

Aciphex CEP

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

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

Aciphex WC

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

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

Aciphex 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 Aciphex as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Aciphex GMP

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

Aciphex CoA

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

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

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