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    Chemistry

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    Also known as: Dantrolene sodium, 14663-23-1, Tox21_500424, Ccg-221728, Ncgc00261109-01, Ac-25752
    Molecular Formula
    C14H9N4NaO5
    Molecular Weight
    336.23  g/mol
    InChI Key
    KSRLIXGNPXAZHD-HAZZGOGXSA-M
    Dantrolene
    Skeletal muscle relaxant that acts by interfering with excitation-contraction coupling in the muscle fiber. It is used in spasticity and other neuromuscular abnormalities. Although the mechanism of action is probably not central, dantrolene is usually grouped with the central muscle relaxants.
    1 2D Structure

    Dantrolene

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;1-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]imidazolidin-3-ide-2,4-dione
    2.1.2 InChI
    InChI=1S/C14H10N4O5.Na/c19-13-8-17(14(20)16-13)15-7-11-5-6-12(23-11)9-1-3-10(4-2-9)18(21)22;/h1-7H,8H2,(H,16,19,20);/q;+1/p-1/b15-7+;
    2.1.3 InChI Key
    KSRLIXGNPXAZHD-HAZZGOGXSA-M
    2.1.4 Canonical SMILES
    C1C(=O)[N-]C(=O)N1N=CC2=CC=C(O2)C3=CC=C(C=C3)[N+](=O)[O-].[Na+]
    2.1.5 Isomeric SMILES
    C1C(=O)[N-]C(=O)N1/N=C/C2=CC=C(O2)C3=CC=C(C=C3)[N+](=O)[O-].[Na+]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Dantrium

    2. Dantrolene

    3. Dantrolene Sodium

    4. Sodium, Dantrolene

    2.2.2 Depositor-Supplied Synonyms

    1. Dantrolene Sodium

    2. 14663-23-1

    3. Tox21_500424

    4. Ccg-221728

    5. Ncgc00261109-01

    6. Ac-25752

    7. D 9175

    2.3 Create Date
    2007-02-08
    3 Chemical and Physical Properties
    Molecular Weight 336.23 g/mol
    Molecular Formula C14H9N4NaO5
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count3
    Exact Mass336.04706368 g/mol
    Monoisotopic Mass336.04706368 g/mol
    Topological Polar Surface Area110 Ų
    Heavy Atom Count24
    Formal Charge0
    Complexity530
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameDantrolene sodium
    Drug LabelThe chemical formula of dantrolene sodium is hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility incre...
    Active IngredientDantrolene sodium
    Dosage FormCapsule
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyMikah Pharma; Impax Labs

    2 of 2  
    Drug NameDantrolene sodium
    Drug LabelThe chemical formula of dantrolene sodium is hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility incre...
    Active IngredientDantrolene sodium
    Dosage FormCapsule
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyMikah Pharma; Impax Labs

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Muscle Relaxants, Central

    A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Decreased Striated Muscle Tone [PE]; Skeletal Muscle Relaxant [EPC]; Decreased Striated Muscle Contraction [PE]

    API Reference Price

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STATES","foreign_port":"TAIPEI","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"100.05","actualQuantity":"100.05","unit":"KGS","unitRateFc":"2200","totalValueFC":"222099.2","currency":"N\/A","unitRateINR":"193050","date":"28-Feb-2025","totalValueINR":"19314652.5","totalValueInUsd":"222099.2","indian_port":"Madras Air","hs_no":"29349990","bill_no":"8613519","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"505 EIGHTH AVENUE, NEW YORK NY 10018 SDNF UNITED STATES","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"}]
    08-Mar-2021
    09-Apr-2025
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    DOSAGE - CAPSULE;ORAL - 100MG

    USFDA APPLICATION NUMBER - 17443

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    DOSAGE - CAPSULE;ORAL - 25MG

    USFDA APPLICATION NUMBER - 17443

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    DOSAGE - CAPSULE;ORAL - 50MG

    USFDA APPLICATION NUMBER - 17443

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    ABOUT THIS PAGE

    Looking for 14663-23-1 / Dantrolene API manufacturers, exporters & distributors?

    Dantrolene manufacturers, exporters & distributors 1

    74

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

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

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

    API | Excipient name

    Dantrolene

    Synonyms

    Dantrolene sodium, 14663-23-1, Tox21_500424, Ccg-221728, Ncgc00261109-01, Ac-25752

    Cas Number

    14663-23-1

    About Dantrolene

    Skeletal muscle relaxant that acts by interfering with excitation-contraction coupling in the muscle fiber. It is used in spasticity and other neuromuscular abnormalities. Although the mechanism of action is probably not central, dantrolene is usually grouped with the central muscle relaxants.

    Dantrolene Manufacturers

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

    Dantrolene Suppliers

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

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

    Dantrolene USDMF

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

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

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

    Dantrolene 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 Dantrolene as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dantrolene GMP

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

    Dantrolene CoA

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

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

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