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Chemistry

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Also known as: 129101-54-8, Rivastigmine hydrogen tartrate, Ena 713, Sdz-ena 713, Rivastigmine bitartrate, Rivastigmine (tartrate)
Molecular Formula
C18H28N2O8
Molecular Weight
400.4  g/mol
InChI Key
GWHQHAUAXRMMOT-MBANBULQSA-N
FDA UNII
9IY2357JPE

Rivastigmine Tartrate
A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.
1 2D Structure

Rivastigmine Tartrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R,3R)-2,3-dihydroxybutanedioic acid;[3-[(1S)-1-(dimethylamino)ethyl]phenyl] N-ethyl-N-methylcarbamate
2.1.2 InChI
InChI=1S/C14H22N2O2.C4H6O6/c1-6-16(5)14(17)18-13-9-7-8-12(10-13)11(2)15(3)4;5-1(3(7)8)2(6)4(9)10/h7-11H,6H2,1-5H3;1-2,5-6H,(H,7,8)(H,9,10)/t11-;1-,2-/m01/s1
2.1.3 InChI Key
GWHQHAUAXRMMOT-MBANBULQSA-N
2.1.4 Canonical SMILES
CCN(C)C(=O)OC1=CC=CC(=C1)C(C)N(C)C.C(C(C(=O)O)O)(C(=O)O)O
2.1.5 Isomeric SMILES
CCN(C)C(=O)OC1=CC=CC(=C1)[C@H](C)N(C)C.[C@@H]([C@H](C(=O)O)O)(C(=O)O)O
2.2 Other Identifiers
2.2.1 UNII
9IY2357JPE
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (s)-n-ethyl-3-((1-dimethyl-amino)ethyl)-n-methylphenylcarbamate

2. 713, Ena

3. 713, Sdz Ena

4. Ena 713

5. Ena 713, Sdz

6. Ena-713

7. Ena713

8. Exelon

9. Hydrogen Tartrate, Rivastigmine

10. Rivastigmine

11. Rivastigmine Hydrogen Tartrate

12. Rivastigminetartrate

13. Sdz Ena 713

14. Tartrate, Rivastigmine Hydrogen

2.3.2 Depositor-Supplied Synonyms

1. 129101-54-8

2. Rivastigmine Hydrogen Tartrate

3. Ena 713

4. Sdz-ena 713

5. Rivastigmine Bitartrate

6. Rivastigmine (tartrate)

7. (s)-3-(1-(dimethylamino)ethyl)phenyl Ethyl(methyl)carbamate (2r,3r)-2,3-dihydroxysuccinate

8. Rivastigmine Hydrogentartrate

9. Rivastigmine Tartrate (exelon)

10. 9iy2357jpe

11. Chebi:64358

12. (2r,3r)-2,3-dihydroxybutanedioic Acid;[3-[(1s)-1-(dimethylamino)ethyl]phenyl] N-ethyl-n-methylcarbamate

13. Rivastigmine Actavis

14. (2r,3r)-2,3-dihydroxybutanedioic Acid 3-[(1s)-1-(dimethylamino)ethyl]phenyl N-ethyl-n-methylcarbamate

15. Carbamic Acid, N-ethyl-n-methyl-, 3-[(1s)-1-(dimethylamino)ethyl]phenyl Ester, (2r,3r)-2,3-dihydroxybutanedioate (1:1)

16. Rivastigmine Tartrate Salt

17. Unii-9iy2357jpe

18. Rivastach

19. Exelon Mr

20. Exelon Tds

21. Nimvastid (tn)

22. Carbamic Acid, N-ethyl-n-methyl-, 3-((1s)-1-(dimethylamino)ethyl)phenyl Ester, (2r,3r)-2,3-dihydroxybutanedioate (1:1)

23. Rivastigmine Tartrate;

24. Rivastigmine L-tartrate

25. Rivastigmine Tartrate [usp]

26. Rivastigmine Tartrate- Bio-x

27. Mls006011143

28. Chembl1201092

29. Hms3678f17

30. Hms3884h05

31. Rivastigmine For System Suitability

32. Act03355

33. Mfcd03700731

34. Rivastigmine Tartrate [vandf]

35. S2087

36. Akos022179413

37. Rivastigmine Tartrate [usp-rs]

38. Ac-3487

39. Ccg-213410

40. Cs-0947

41. T01r548

42. As-13921

43. Br164357

44. Carbamic Acid, Ethylmethyl-, 3-((1s)-1-(dimethylamino)ethyl)phenyl Ester, (2r,3r)-2,3-dihydroxybutanedioate (1:1)

45. Carbamic Acid, Ethylmethyl-, 3-(1-(dimethylamino)ethyl)phenyl Ester, (s)-, (r-(r*,r*))-2,3-dihydroxybutanedioate (1:1)

46. Hy-11017

47. N-ethyl-n-methylcarbamic Acid 3-[(1s)-1-(dimethylamino)ethyl]phenyl Ester (2r,3r)-2,3-dihydroxybutanedioate

48. Smr004702920

49. Rivastigmine (as Hydrogen Tartrate)

50. Rivastigmine Hydrogen Tartrate [mi]

51. Rivastigmine Tartrate [orange Book]

52. Am20080949

53. R0093

54. Rivastigmine Tartrate [usp Monograph]

55. Sw199663-2

56. Rivastigmine Hydrogen Tartrate [mart.]

57. D02558

58. Rivastigmine Hydrogen Tartrate [who-dd]

59. Rivastigmine Hydrogen Tartrate [ema Epar]

60. Q-101313

61. Rivastigmine Hydrogen Tartrate [ep Monograph]

62. Q27133236

63. 3-[(s)-1-(dimethylamino)ethyl]phenyl N-ethyl-n-methylcarbamate L-tartrate

64. N-ethyl-n-methylcarbamic Acid 3-[(s)-1-(dimethylamino)ethyl]phenyl Ester L-tartrate

65. (1s)-1-(3-{[ethyl(methyl)carbamoyl]oxy}phenyl)-n,n-dimethylethanaminium (2r,3r)-3-carboxy-2,3-dihydroxypropanoate

66. 3-[(1s)-1-(dimethylamino)ethyl]phenyl Ethyl(methyl)carbamate (2r,3r)-2,3-dihydroxybutanedioate

2.4 Create Date
2006-07-28
3 Chemical and Physical Properties
Molecular Weight 400.4 g/mol
Molecular Formula C18H28N2O8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count9
Rotatable Bond Count8
Exact Mass400.18456586 g/mol
Monoisotopic Mass400.18456586 g/mol
Topological Polar Surface Area148 Ų
Heavy Atom Count28
Formal Charge0
Complexity402
Isotope Atom Count0
Defined Atom Stereocenter Count3
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 NameRivastigmine tartrate
Drug LabelRivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological...
Active IngredientRivastigmine tartrate
Dosage FormCapsule
Routeoral; Oral
Strengtheq 4.5mg base; eq 6mg base; eq 1.5mg base; eq 3mg base
Market StatusTentative Approval; Prescription
CompanyApotex; Alembic Pharms; Sun Pharm Inds; Watson Labs; Macleods Pharms; Dr Reddys Labs; Orchid Hlthcare

2 of 2  
Drug NameRivastigmine tartrate
Drug LabelRivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological...
Active IngredientRivastigmine tartrate
Dosage FormCapsule
Routeoral; Oral
Strengtheq 4.5mg base; eq 6mg base; eq 1.5mg base; eq 3mg base
Market StatusTentative Approval; Prescription
CompanyApotex; Alembic Pharms; Sun Pharm Inds; Watson Labs; Macleods Pharms; Dr Reddys Labs; Orchid Hlthcare

4.2 Drug Indication

Symptomatic treatment of mild to moderately severe Alzheimer's dementia.

Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.


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.)


Neuroprotective Agents

Drugs intended to prevent damage to the brain or spinal cord from ischemia, stroke, convulsions, or trauma. Some must be administered before the event, but others may be effective for some time after. They act by a variety of mechanisms, but often directly or indirectly minimize the damage produced by endogenous excitatory amino acids. (See all compounds classified as Neuroprotective Agents.)


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

N06DA03


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MAHARASHTRA","supplier":"UNIMED TECHNOLOGIES LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"CITIBANK N.A","customerCountry":"BANGLADESH","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"4500","totalValueFC":"44657.6","currency":"USD","unitRateINR":371157.18199999997,"date":"08-Jan-2024","totalValueINR":"3711571.82","totalValueInUsd":"44657.6","indian_port":"Bombay Air","hs_no":"29242990","bill_no":"6585966","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"FP 145, RAM MANDIR RD.,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706121000,"product":"RIVASTIGMINE TARTRATE USP","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"ACHE LABORATORIOS 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22-Mar-2021
19-Sep-2024
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DOSAGE - CAPSULE;ORAL - EQ 1.5MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 1.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20823

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DOSAGE - CAPSULE;ORAL - EQ 3MG BASE **Federal...DOSAGE - CAPSULE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20823

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DOSAGE - CAPSULE;ORAL - EQ 4.5MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 4.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20823

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DOSAGE - CAPSULE;ORAL - EQ 6MG BASE **Federal...DOSAGE - CAPSULE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20823

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ABOUT THIS PAGE

Rivastigmine Tartrate Manufacturers

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

Rivastigmine Tartrate Suppliers

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

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

Rivastigmine Tartrate USDMF

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

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

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

Rivastigmine Tartrate KDMF

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

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

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

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

Rivastigmine Tartrate CEP

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

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

Rivastigmine Tartrate WC

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

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

Rivastigmine Tartrate 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 Rivastigmine Tartrate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Rivastigmine Tartrate GMP

Rivastigmine Tartrate 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 Rivastigmine Tartrate 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 Rivastigmine Tartrate GMP manufacturer or Rivastigmine Tartrate GMP API supplier for your needs.

Rivastigmine Tartrate CoA

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

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

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