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Also known as: Ibuprofen lysine, 57469-76-8, Ibuprofen dl-lysine, Ibuprofen d,l-lysinate, 079x7dl13m, (rs)-2-(4-(2-methylpropyl)phenyl)propanoic acid d,l-lysine salt
Molecular Formula
C19H32N2O4
Molecular Weight
352.5  g/mol
InChI Key
IHHXIUAEPKVVII-UHFFFAOYSA-N
FDA UNII
079X7DL13M

Ibuprofen Lysinate
1 2D Structure

Ibuprofen Lysinate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2,6-diaminohexanoic acid;2-[4-(2-methylpropyl)phenyl]propanoic acid
2.1.2 InChI
InChI=1S/C13H18O2.C6H14N2O2/c1-9(2)8-11-4-6-12(7-5-11)10(3)13(14)15;7-4-2-1-3-5(8)6(9)10/h4-7,9-10H,8H2,1-3H3,(H,14,15);5H,1-4,7-8H2,(H,9,10)
2.1.3 InChI Key
IHHXIUAEPKVVII-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)CC1=CC=C(C=C1)C(C)C(=O)O.C(CCN)CC(C(=O)O)N
2.2 Other Identifiers
2.2.1 UNII
079X7DL13M
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Ibuprofen Lysine

2. 57469-76-8

3. Ibuprofen Dl-lysine

4. Ibuprofen D,l-lysinate

5. 079x7dl13m

6. (rs)-2-(4-(2-methylpropyl)phenyl)propanoic Acid D,l-lysine Salt

7. 2,6-diaminohexanoic Acid Compound With 2-(4-isobutylphenyl)propanoic Acid (1:1)

8. (rs)-2-[4-(2-methylpropyl)phenyl]propanoic Acid D,l-lysine Salt

9. (2s)-2,6-diaminohexanoic Acid;2-[4-(2-methylpropyl)phenyl]propanoic Acid

10. Neoprofen;ibuprofen-lys

11. Starbld0004237

12. Schembl44616

13. Unii-079x7dl13m

14. Dtxsid50432054

15. Bcp27681

16. Akos015963349

17. Ac-19865

18. Ac-32764

19. Ft-0670261

20. Ft-0670262

21. Lysine, Mono(alpha-methyl-4-(2-methylpropyl)benzeneacetate)

22. Dl-lysine, Mono(alpha-methyl-4-(2-methylpropyl)benzeneacetate)

23. Lysine, Alpha-methyl-4-(2-methylpropyl)benzeneacetate (1:1)

24. Dl-lysine, Mono(.alpha.-methyl-4-(2-methylpropyl)benzeneacetate)

25. Lysine, .alpha.-methyl-4-(2-methylpropyl)benzeneacetate (1:1)

26. Lysine, Mono(.alpha.-methyl-4-(2-methylpropyl)benzeneacetate)

27. Benzeneacetic Acid, .alpha.-methyl-4-(2-methylpropyl)-, Compd. With Lysine (1:1)

28. Benzeneacetic Acid, Alpha-methyl-4-(2-methylpropyl)-, Compd. With Lysine (1:1)

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 352.5 g/mol
Molecular Formula C19H32N2O4
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count9
Exact Mass352.23620751 g/mol
Monoisotopic Mass352.23620751 g/mol
Topological Polar Surface Area127 Ų
Heavy Atom Count25
Formal Charge0
Complexity309
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 FDA Pharmacological Classification
4.1.1 Pharmacological Classes
Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

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19-Jan-2021
18-Nov-2024
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ABOUT THIS PAGE

Ibuprofen Lysine Manufacturers

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

Ibuprofen Lysine Suppliers

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

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

Ibuprofen Lysine USDMF

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

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

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

Ibuprofen Lysine WC

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

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

Ibuprofen Lysine 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 Ibuprofen Lysine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ibuprofen Lysine GMP

Ibuprofen Lysine 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 Ibuprofen Lysine 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 Ibuprofen Lysine GMP manufacturer or Ibuprofen Lysine GMP API supplier for your needs.

Ibuprofen Lysine CoA

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

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

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