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Chemistry

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Also known as: N-[2-[4-[n-(hexyloxycarbonyl)amidino]phenylaminomethyl]-1-methyl-1h-benzimidazol-5-ylcarbonyl]-n-(2-pyridyl)-beta-alanine ethyl ester, Rabigatran etexilate, Bibr1048, Bcpp000269, Bibr-1048 - dabigatran etexilate, Akos015900928
Molecular Formula
C34H41N7O5
Molecular Weight
627.7  g/mol
InChI Key
KSGXQBZTULBEEQ-UHFFFAOYSA-N

Pradax
1 2D Structure

Pradax

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
ethyl 3-[[2-[[4-[(Z)-N'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate
2.1.2 InChI
InChI=1S/C34H41N7O5/c1-4-6-7-10-21-46-34(44)39-32(35)24-12-15-26(16-13-24)37-23-30-38-27-22-25(14-17-28(27)40(30)3)33(43)41(20-18-31(42)45-5-2)29-11-8-9-19-36-29/h8-9,11-17,19,22,37H,4-7,10,18,20-21,23H2,1-3H3,(H2,35,39,44)
2.1.3 InChI Key
KSGXQBZTULBEEQ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCCCOC(=O)N=C(C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)N
2.1.5 Isomeric SMILES
CCCCCCOC(=O)/N=C(/C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)\N
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. N-[2-[4-[n-(hexyloxycarbonyl)amidino]phenylaminomethyl]-1-methyl-1h-benzimidazol-5-ylcarbonyl]-n-(2-pyridyl)-beta-alanine Ethyl Ester

2. Rabigatran Etexilate

3. Bibr1048

4. Bcpp000269

5. Bibr-1048 - Dabigatran Etexilate

6. Akos015900928

7. Am81239

8. Bcp9000578

9. Bs-1001

10. Ncgc00390544-02

11. Ab01563294_01

12. 915b069

13. Q-102504

14. Hexyl2-(4-(((5-((3-ethoxy-3-oxopropyl)(pyridin-2-yl)carbamoyl)-1-methyl-1h-benzo[d]imidazol-2-yl)methyl)amino)benzylidene)hydrazinecarboxylate

2.3 Create Date
2006-04-28
3 Chemical and Physical Properties
Molecular Weight 627.7 g/mol
Molecular Formula C34H41N7O5
XLogP35.7
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count17
Exact Mass627.31691743 g/mol
Monoisotopic Mass627.31691743 g/mol
Topological Polar Surface Area154 Ų
Heavy Atom Count46
Formal Charge0
Complexity1000
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NamePRADAXA
Active IngredientDABIGATRAN ETEXILATE MESYLATE
CompanyBOEHRINGER INGELHEIM (Application Number: N022512. Patents: 6087380, 7866474, 7932273, 9034822)

ABOUT THIS PAGE

Pradax Manufacturers

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

Pradax Suppliers

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

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

Pradax GMP

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

Pradax CoA

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

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

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