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    Also known as: 2016-36-6, Syrap, (2-hydroxyethyl)trimethylammonium salicylate, Choline salicylic acid salt, Salicylic acid choline salt, Choline, salicylate (salt)
    Molecular Formula
    C12H19NO4
    Molecular Weight
    241.28  g/mol
    InChI Key
    UDKCHVLMFQVBAA-UHFFFAOYSA-M
    FDA UNII
    KD510K1IQW
    Choline Salicylate
    Choline Salicylate is the choline salt of salicylic acid, a nonsteroidal anti-inflammatory drug (NSAID), with analgesic, antipyretic, anti-inflammatory, anti-rheumatic and immunomodulating activities. Upon oral administration, salicylic acid irreversibly acetylates cyclooxygenases I and II, thereby inhibiting prostaglandin (PG) synthesis and the PG-associated inflammation, fever and pain. This agent may induce cancer cell apoptosis and modulate the immune response.
    1 2D Structure

    Choline Salicylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-carboxyphenolate;2-hydroxyethyl(trimethyl)azanium
    2.1.2 InChI
    InChI=1S/C7H6O3.C5H14NO/c8-6-4-2-1-3-5(6)7(9)10;1-6(2,3)4-5-7/h1-4,8H,(H,9,10);7H,4-5H2,1-3H3/q;+1/p-1
    2.1.3 InChI Key
    UDKCHVLMFQVBAA-UHFFFAOYSA-M
    2.1.4 Canonical SMILES
    C[N+](C)(C)CCO.C1=CC=C(C(=C1)C(=O)O)[O-]
    2.2 Other Identifiers
    2.2.1 UNII
    KD510K1IQW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Mundasal

    2. Mundisal

    2.3.2 Depositor-Supplied Synonyms

    1. 2016-36-6

    2. Syrap

    3. (2-hydroxyethyl)trimethylammonium Salicylate

    4. Choline Salicylic Acid Salt

    5. Salicylic Acid Choline Salt

    6. Choline, Salicylate (salt)

    7. Cholin Salicylate

    8. Salicylic Acid, Ion(1-), Choline

    9. Choline Subsalicylate

    10. 2-hydroxy-n,n,n-trimethylethanaminium 2-hydroxybenzoate

    11. Ethanaminium, 2-hydroxy-n,n,n-trimethyl-, Salt With 2-hydroxybenzoic Acid (1:1)

    12. Kd510k1iqw

    13. Arthropan

    14. 2-hydroxy-n,n,n-trimethylethanaminium Salt With 2-hydroxybenzoic Acid (1:1)

    15. Actasal

    16. Artrobione

    17. Mundisal

    18. Salicol

    19. Satibon

    20. Arret

    21. 2-hydroxybenzoate;2-hydroxyethyl(trimethyl)azanium

    22. 2-carboxyphenolate;2-hydroxyethyl(trimethyl)azanium

    23. Choline Salicylate B

    24. Cholinesalicylate

    25. Ethanaminium, 2-hydroxy-n,n,n-trimethyl-, 2-hydroxybenzoate (1:1)

    26. Cholini Salicylas

    27. Salicilato De Colina

    28. Cholini Salicylas [inn-latin]

    29. Salicylate De Choline

    30. Salicilato De Colina [inn-spanish]

    31. Salicylate De Choline [inn-french]

    32. Einecs 217-948-8

    33. Unii-kd510k1iqw

    34. Choline Salicylate [usan:inn:ban:jan]

    35. Arthropan (tn)

    36. Choline Salicylate (salt)

    37. Schembl3960

    38. Chebi:3668

    39. Choline Salicylate [mi]

    40. Chembl2104095

    41. Choline Salicylate [inn]

    42. Choline Salicylate [jan]

    43. Dtxsid8062103

    44. Choline Salicylate [usan]

    45. Choline Salicylate [vandf]

    46. Choline Salicylate [mart.]

    47. Choline Salicylate [who-dd]

    48. Choline Salicylate (jan/usan/inn)

    49. Mfcd00242760

    50. Akos030228339

    51. Db14006

    52. As-66082

    53. Cs-0449641

    54. D00810

    55. (2-hydroxyethyl)trimethylazanium 2-hydroxybenzoate

    56. A909239

    57. (2-hydroxyethyl)trimethyl Ammonium Salicylate

    58. 2-carboxyphenolate,2-hydroxyethyl(trimethyl)azanium

    59. Q4499058

    60. (2-hydroxyethyl)trimethylammonium 2-hydroxybenzoate

    61. 2-hydroxy-n,n,n-trimethylethan-1-aminium 2-hydroxybenzoate

    62. 2-hydroxy-n,n,n-trimethylethan-1-aminium 2-carboxyphenolate

    63. Benzoic Acid, 2-hydroxy-, Ion(1-), 2-hydroxy-n,n,n-trimethylethanaminium

    2.4 Create Date
    2011-12-26
    3 Chemical and Physical Properties
    Molecular Weight 241.28 g/mol
    Molecular Formula C12H19NO4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count3
    Exact Mass241.13140809 g/mol
    Monoisotopic Mass241.13140809 g/mol
    Topological Polar Surface Area80.6 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity179
    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 Indication

    The oral gel is indicated for the relief of pain and discomfort of common mouth ulcers, cold sores, denture sore spots, infant teething and mouth ulcers, and sore spots due to orthodontic devices in children.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    This is an anti-inflammatory and antipyretic medication,. If is often used in oral gel form for the relief of pain, discomfort, and inflammation caused by common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots because of orthodontic devices.

    5.2 ATC Code

    N - Nervous system

    N02 - Analgesics

    N02B - Other analgesics and antipyretics

    N02BA - Salicylic acid and derivatives

    N02BA03 - Choline salicylate

    5.3 Absorption, Distribution and Excretion

    Absorption

    Onset: 1-2 hr after ingestion In the oral form, choline salicylate is absorbed across the buccal mucosa. There is a need for caution not to exceed the stated dose and monitor for any signs of suggested salicylism, especially when this drug is used for infants. In one study, it was found that this drug was more rapidly absorbed than ASA (absorption t1/2 = 0.1 vs 0.36 h).

    Route of Elimination

    Both metabolites of choline salicylate, and a small amount of intact salicylic acid are excreted, primarily in the urine.

    Volume of Distribution

    0.15 L/kg (salicylate), and widely distributed throughout extracellular water and most tissues

    5.4 Metabolism/Metabolites

    The metabolism of salicylic acid is by glycine and phenolic or acyl glucuronate conjugation with small amounts of the drug undergoing hydroxylation. Extensively metabolized in the liver; inactive metabolites are excreted by the kidneys.

    5.5 Biological Half-Life

    The plasma half-life of salicylic acid is 2-4 hours. Up to 15 30 h with larger doses due to saturation of liver metabolism capacity.

    5.6 Mechanism of Action

    Choline salicylate relieves pain by inhibition of prostaglandin synthesis and reduces fever by acting on the hypothalamus heat-regulating center. It also inhibits the generation of impulses through the inhibition of cyclooxygenase enzyme (COX),. Cyclooxygenase is involved in the production of prostaglandins, in response to injury and after various other stimuli. The prostaglandins promote pain, swelling, and inflammation. The choline salicylate decreases inflammation and pain by reducing the production of these prostaglandins in the area of the mouth it is applied to.

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    Choline Salicylate Manufacturers

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

    Choline Salicylate Suppliers

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

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

    Choline Salicylate USDMF

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

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

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

    Choline Salicylate WC

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

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

    Choline Salicylate 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 Choline Salicylate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Choline Salicylate GMP

    Choline Salicylate 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 Choline Salicylate 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 Choline Salicylate GMP manufacturer or Choline Salicylate GMP API supplier for your needs.

    Choline Salicylate CoA

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

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

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