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Chemistry

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Also known as: 58895-64-0, Nalmefene hcl, Revex, Nalmefenehydrochloride, Jf-1 hydrochloride, K7k69qc05x
Molecular Formula
C21H26ClNO3
Molecular Weight
375.9  g/mol
InChI Key
GYWMRGWFQPSQLK-OPHZJPRHSA-N
FDA UNII
K7K69QC05X

Nalmefene Hydrochloride
Nalmefene Hydrochloride is the hydrochloride salt form of nalmefene, a naltrexone analogue with opioid antagonistic property. Nalmefene antagonizes the effects of opioids by competing for the opioid receptors in the CNS. This results in reversal of the effects of the opioids, including reversal of analgesia, euphoria, respiratory depression, hypotension, sedation and physical dependence.
1 2D Structure

Nalmefene Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,4aS,7aS,12bS)-3-(cyclopropylmethyl)-7-methylidene-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol;hydrochloride
2.1.2 InChI
InChI=1S/C21H25NO3.ClH/c1-12-6-7-21(24)16-10-14-4-5-15(23)18-17(14)20(21,19(12)25-18)8-9-22(16)11-13-2-3-13;/h4-5,13,16,19,23-24H,1-3,6-11H2;1H/t16-,19+,20+,21-;/m1./s1
2.1.3 InChI Key
GYWMRGWFQPSQLK-OPHZJPRHSA-N
2.1.4 Canonical SMILES
C=C1CCC2(C3CC4=C5C2(C1OC5=C(C=C4)O)CCN3CC6CC6)O.Cl
2.1.5 Isomeric SMILES
C=C1CC[C@]2([C@H]3CC4=C5[C@]2([C@H]1OC5=C(C=C4)O)CCN3CC6CC6)O.Cl
2.2 Other Identifiers
2.2.1 UNII
K7K69QC05X
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 6-desoxy-6-methylenenaltrexone

2. Nalmefene

3. Revex

4. Selincro

2.3.2 Depositor-Supplied Synonyms

1. 58895-64-0

2. Nalmefene Hcl

3. Revex

4. Nalmefenehydrochloride

5. Jf-1 Hydrochloride

6. K7k69qc05x

7. (4r,4as,7as,12bs)-3-(cyclopropylmethyl)-7-methylidene-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol;hydrochloride

8. Unii-k7k69qc05x

9. Revex (tn)

10. 17-(cyclopropylmethyl)-4,5alpha-epoxy-6-methylenemorphinan-3,14-diol, , Hydrochloride

11. Schembl628721

12. Chembl1201152

13. Dtxsid70891705

14. Bcp08346

15. Nalmefene Hydrochloride [mi]

16. Mfcd27937056

17. Akos016340557

18. Ccg-221179

19. Hs-0037

20. Nalmefene Hydrochloride [mart.]

21. Nalmefene Hydrochloride [vandf]

22. Nalmefene Hydrochloride [who-dd]

23. Morphinan-3,14-diol, 17-(cyclopropylmethyl)-4,5-epoxy-6-methylene-, Hydrochloride, (5alpha)-

24. B7584

25. Nalmefene Hydrochloride [orange Book]

26. D02104

27. Sr-01000000007

28. Sr-01000000007-2

29. Q27282058

30. 17-cyclopropylmethyl-4,5a-epoxy-6-methylenemorphinan-3,14-diol

31. (5?)-17-(cyclopropylmethyl)-4,5-epoxy-6-methylenemorphinan-3,14-diol Hydrochloride

32. 17-cyclopropylmethyl-4,5a-epoxy-6-methylenemorphinan-3,14-diol Hydrochloride

33. (4r,4as,7as,12bs)-3-(cyclopropylmethyl)-7-methylidene-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol,hydrochloride

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 375.9 g/mol
Molecular Formula C21H26ClNO3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass375.1601214 g/mol
Monoisotopic Mass375.1601214 g/mol
Topological Polar Surface Area52.9 Ų
Heavy Atom Count26
Formal Charge0
Complexity618
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Narcotic Antagonists

Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Opioid Antagonists [MoA]; Opioid Antagonist [EPC]

API Reference Price

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08-Jan-2021
23-Nov-2024
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ABOUT THIS PAGE

Looking for 58895-64-0 / Nalmefene Hydrochloride API manufacturers, exporters & distributors?

Nalmefene Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Nalmefene Hydrochloride

Synonyms

58895-64-0, Nalmefene hcl, Revex, Nalmefenehydrochloride, Jf-1 hydrochloride, K7k69qc05x

Cas Number

58895-64-0

Unique Ingredient Identifier (UNII)

K7K69QC05X

About Nalmefene Hydrochloride

Nalmefene Hydrochloride is the hydrochloride salt form of nalmefene, a naltrexone analogue with opioid antagonistic property. Nalmefene antagonizes the effects of opioids by competing for the opioid receptors in the CNS. This results in reversal of the effects of the opioids, including reversal of analgesia, euphoria, respiratory depression, hypotension, sedation and physical dependence.

Nalmefene Hydrochloride Manufacturers

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

Nalmefene Hydrochloride Suppliers

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

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

Nalmefene Hydrochloride USDMF

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

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

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

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

Nalmefene Hydrochloride WC

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

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

Nalmefene Hydrochloride 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 Nalmefene Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Nalmefene Hydrochloride GMP

Nalmefene Hydrochloride 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 Nalmefene Hydrochloride 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 Nalmefene Hydrochloride GMP manufacturer or Nalmefene Hydrochloride GMP API supplier for your needs.

Nalmefene Hydrochloride CoA

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

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

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