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    Chemistry

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    Also known as: 502-85-2, Sodium 4-hydroxybutyrate, Anetamin, 4-hydroxybutyric acid sodium salt, Sodium 4-hydroxybutanoate, Somsanit
    Molecular Formula
    C4H7NaO3
    Molecular Weight
    126.09  g/mol
    InChI Key
    XYGBKMMCQDZQOZ-UHFFFAOYSA-M
    FDA UNII
    7G33012534
    Sodium Oxybate
    The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.
    1 2D Structure

    Sodium Oxybate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;4-hydroxybutanoate
    2.1.2 InChI
    InChI=1S/C4H8O3.Na/c5-3-1-2-4(6)7;/h5H,1-3H2,(H,6,7);/q;+1/p-1
    2.1.3 InChI Key
    XYGBKMMCQDZQOZ-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C(CC(=O)[O-])CO.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    7G33012534
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4 Hydroxybutyrate Sodium

    2. 4-hydroxybutyrate Sodium

    3. Gamma Hydroxybutyrate

    4. Gamma-hydroxybutyrate

    5. Oxybate Sodium

    6. Oxybate, Sodium

    7. Oxybutyrate, Sodium

    8. Sodium Gamma Hydroxybutyrate

    9. Sodium Gamma-hydroxybutyrate

    10. Sodium Oxybutyrate

    11. Somsanit

    12. Xyrem

    2.3.2 Depositor-Supplied Synonyms

    1. 502-85-2

    2. Sodium 4-hydroxybutyrate

    3. Anetamin

    4. 4-hydroxybutyric Acid Sodium Salt

    5. Sodium 4-hydroxybutanoate

    6. Somsanit

    7. Oxybate Sodium

    8. Gamma Oh

    9. Sodium Oxybate [usan]

    10. Sodium Oxybutyrate

    11. Catabate

    12. Sodium Oxybat

    13. Oxybate (sodium)

    14. 4-hydroxybutyrate Sodium

    15. Wy-3478

    16. Butanoic Acid, 4-hydroxy-, Monosodium Salt

    17. Gamma-hydroxybutyrate Sodium

    18. Sodium Gamma-hydroxybutyrate

    19. Sodium;4-hydroxybutanoate

    20. Gamma-hydroxy Sodium Butyrate

    21. Butanoic Acid, 4-hydroxy-, Sodium Salt

    22. Eb 27

    23. Hydroxybutyric Acid Monosodium Salt

    24. 4-hydroxybutyric Acid Monosodium Salt

    25. Wy 3478

    26. .gamma.-hydroxybutyrate Sodium Salt

    27. Nsc-84223

    28. Sodium Oxybate (usan)

    29. 7g33012534

    30. Butyric Acid, 4-hydroxy-, Monosodium Salt

    31. Butyric Acid, 4-hydroxy-, Sodium Salt

    32. Natrium 4-hydroxybutyrat

    33. Sodium-4-hydroxybutyrate

    34. Sodium Oxybate (sodium 4-hydroxybutanoate)

    35. Ghb Sodium Salt (sodium Gammahydroxybutyrate)

    36. 4-hydroxybuttersaeure Natriumsalz

    37. Gamma-hydroxybutyrate Sodium Salt

    38. Ncgc00247714-01

    39. Einecs 207-953-3

    40. Nsc 84223

    41. Gamma-hydroxybutyric Acid, Sodium Salt

    42. Jzp-6

    43. Sodium4-hydroxybutyrate

    44. Acetamide,2,2-dichloro-n-[(1r,2r)-2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]-,rel-

    45. Unii-7g33012534

    46. Xyrem (tn)

    47. Sodium Gammahydroxybutyrate

    48. Dsstox_cid_28866

    49. Dsstox_rid_83135

    50. Dsstox_gsid_48940

    51. Schembl61823

    52. Sodium Oxybate [hsdb]

    53. Sodium Oxybate [vandf]

    54. Dea No. 2012

    55. Sodium Oxybate [mart.]

    56. Chembl1200682

    57. Dtxsid3048940

    58. Oxybate Sodium [who-dd]

    59. Sodium Oxybate [ema Epar]

    60. Hms2091e15

    61. Hy-b1187

    62. Tox21_112871

    63. Sodium Oxybate [orange Book]

    64. Gamma Hydroxybutyric Acid Preparations

    65. Xywav Component Sodium Oxybate

    66. Akos006221428

    67. Ccg-212465

    68. Cs-4796

    69. Db09072

    70. Sodium Oxybate Component Of Xywav

    71. Cas-502-85-2

    72. Db-071156

    73. Ft-0626615

    74. D05866

    75. H-4040

    76. Sodium Salt Of Gamma-hydroxybutyric Acid

    77. .gamma.-hydroxybutyrate Sodium Salt [mi]

    78. Butanoic Acid, 4-hydroxy-, Sodium Salt (1:1)

    79. Q7553347

    80. 90318-49-3

    2.4 Create Date
    2008-02-05
    3 Chemical and Physical Properties
    Molecular Weight 126.09 g/mol
    Molecular Formula C4H7NaO3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count3
    Exact Mass126.02928836 g/mol
    Monoisotopic Mass126.02928836 g/mol
    Topological Polar Surface Area60.4 Ų
    Heavy Atom Count8
    Formal Charge0
    Complexity64.3
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 NameXyrem
    PubMed HealthSodium Oxybate (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelSodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:Sodium oxyb...
    Active IngredientSodium oxybate
    Dosage FormSolution
    RouteOral
    Strength500mg/ml
    Market StatusPrescription
    CompanyJazz Pharms

    2 of 2  
    Drug NameXyrem
    PubMed HealthSodium Oxybate (By mouth)
    Drug ClassesCentral Nervous System Agent
    Drug LabelSodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:Sodium oxyb...
    Active IngredientSodium oxybate
    Dosage FormSolution
    RouteOral
    Strength500mg/ml
    Market StatusPrescription
    CompanyJazz Pharms

    4.2 Drug Indication

    For the treatment of cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.

    FDA Label

    Treatment of narcolepsy with cataplexy in adult patients.

    Substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. Treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended. ,

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Sodium oxybate works through an unknown mechanism to treat narcolepsy by inducing sleep within about 5-15 minutes of administration.

    5.2 MeSH Pharmacological Classification

    Adjuvants, Anesthesia

    Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

    Anesthetics, Intravenous

    Ultrashort-acting anesthetics that are used for induction. Loss of consciousness is rapid and induction is pleasant, but there is no muscle relaxation and reflexes frequently are not reduced adequately. Repeated administration results in accumulation and prolongs the recovery time. Since these agents have little if any analgesic activity, they are seldom used alone except in brief minor procedures. (From AMA Drug Evaluations Annual, 1994, p174) (See all compounds classified as Anesthetics, Intravenous.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Central Nervous System Depression [PE]; Decreased Central Nervous System Organized Electrical Activity [PE]; Central Nervous System Depressant [EPC]
    5.4 ATC Code

    N07XX04

    N07BB

    B05XA02

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    N - Nervous system

    N01 - Anesthetics

    N01A - Anesthetics, general

    N01AX - Other general anesthetics

    N01AX11 - Sodium oxybate

    N - Nervous system

    N07 - Other nervous system drugs

    N07X - Other nervous system drugs

    N07XX - Other nervous system drugs

    N07XX04 - Sodium oxybate

    5.5 Absorption, Distribution and Excretion

    Absorption

    Absolute bioavailability is approximately 88%. Tmax of 30.7-51.9min.

    Route of Elimination

    The major metabolite is carbon dioxide which is cleared by expiration, less then 5% appears as the unchanged drug in the urine within 6-8 hours after dosing.

    Volume of Distribution

    Vd of 37.7-67.7

    Clearance

    Total clearance of 895-1361mL/min.

    5.6 Metabolism/Metabolites

    Animal studies indicate that the major elimination pathway is metabolism by the creation of carbon dioxide and water through the Krebs cycle and secondarily by beta-oxidation. In the primary pathway hydroxyacid-oxoacid transhydrogenase catalyzes the conversion of sodium oxybate to succinic semialdehyde which is then transformed to succinic acid by succinic semmialdehyde dehydrogenase. Succinic acid is then turned into carbon dioxide and water in the Krebs cycle. Succinic semialdehyde is also metabolised into carbon dioxide and water by a transhydrofenase in the presence of alpha ketoglutarate.

    5.7 Biological Half-Life

    0.5 to 1 hour.

    5.8 Mechanism of Action

    The exact mechanism of action is unknown. It is the sodium salt of the endogenous compound gamma hydroxybutyrate which is a metabolite of the GABA neurotransmitter and it's thought that it's therapeutic effects are mediated via GABA B actions at noradrenergic, dopaminergic and thalamocortical neurons.

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    19-Mar-2025
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    ABOUT THIS PAGE

    Looking for 90318-49-3 / Gamma-Hydroxybutyric Acid Sodium API manufacturers, exporters & distributors?

    Gamma-Hydroxybutyric Acid Sodium manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Gamma-Hydroxybutyric Acid Sodium 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 Gamma-Hydroxybutyric Acid Sodium manufacturer or Gamma-Hydroxybutyric Acid Sodium supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gamma-Hydroxybutyric Acid Sodium manufacturer or Gamma-Hydroxybutyric Acid Sodium supplier.

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

    API | Excipient name

    Gamma-Hydroxybutyric Acid Sodium

    Synonyms

    502-85-2, Sodium 4-hydroxybutyrate, Anetamin, 4-hydroxybutyric acid sodium salt, Sodium 4-hydroxybutanoate, Somsanit

    Cas Number

    90318-49-3

    Unique Ingredient Identifier (UNII)

    7G33012534

    About Gamma-Hydroxybutyric Acid Sodium

    The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA.

    gamma-Hydroxybutyric acid sodium salt Manufacturers

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

    gamma-Hydroxybutyric acid sodium salt Suppliers

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

    click here to find a list of gamma-Hydroxybutyric acid sodium salt suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    gamma-Hydroxybutyric acid sodium salt USDMF

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

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

    click here to find a list of gamma-Hydroxybutyric acid sodium salt suppliers with USDMF on PharmaCompass.

    gamma-Hydroxybutyric acid sodium salt WC

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

    click here to find a list of gamma-Hydroxybutyric acid sodium salt suppliers with Written Confirmation (WC) on PharmaCompass.

    gamma-Hydroxybutyric acid sodium salt 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 gamma-Hydroxybutyric acid sodium salt as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of gamma-Hydroxybutyric acid sodium salt suppliers with NDC on PharmaCompass.

    gamma-Hydroxybutyric acid sodium salt GMP

    gamma-Hydroxybutyric acid sodium salt 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 gamma-Hydroxybutyric acid sodium salt 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 gamma-Hydroxybutyric acid sodium salt GMP manufacturer or gamma-Hydroxybutyric acid sodium salt GMP API supplier for your needs.

    gamma-Hydroxybutyric acid sodium salt CoA

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

    gamma-Hydroxybutyric acid sodium salt CoA mostly includes findings from lab analyses of a specific batch. For each gamma-Hydroxybutyric acid sodium salt 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.

    gamma-Hydroxybutyric acid sodium salt may be tested according to a variety of international standards, such as European Pharmacopoeia (gamma-Hydroxybutyric acid sodium salt EP), gamma-Hydroxybutyric acid sodium salt JP (Japanese Pharmacopeia) and the US Pharmacopoeia (gamma-Hydroxybutyric acid sodium salt 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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