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    Chemistry

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    Also known as: Colazal, 213594-60-6, 82101-18-6, Balsalazide sodium, Colazide, Bx-661a
    Molecular Formula
    C17H13N3Na2O6
    Molecular Weight
    401.28  g/mol
    InChI Key
    CKMOQBVBEGCJGW-UHFFFAOYSA-L
    FDA UNII
    15ASW03C9S
    Balsalazide Disodium
    Balsalazide Disodium is the disodium salt form of balsalazide, an aminosalicylate and oral prodrug that is enzymatically cleaved in the colon to produce the anti-inflammatory agent mesalazine. Mesalazine acts locally on the mucosa of the colon where it diminishes inflammation by blocking the production of arachidonic acid metabolites, including leukotrienes, prostaglandins and hydroxyeicosatetraenoic acids, and other inflammatory agents. Balsalazide disodium is used to treat chronic inflammatory bowel disease.
    1 2D Structure

    Balsalazide Disodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    disodium;3-[[4-[(3-carboxy-4-oxidophenyl)diazenyl]benzoyl]amino]propanoate
    2.1.2 InChI
    InChI=1S/C17H15N3O6.2Na/c21-14-6-5-12(9-13(14)17(25)26)20-19-11-3-1-10(2-4-11)16(24)18-8-7-15(22)23;;/h1-6,9,21H,7-8H2,(H,18,24)(H,22,23)(H,25,26);;/q;2*+1/p-2
    2.1.3 InChI Key
    CKMOQBVBEGCJGW-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    C1=CC(=CC=C1C(=O)NCCC(=O)[O-])N=NC2=CC(=C(C=C2)[O-])C(=O)O.[Na+].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    15ASW03C9S
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-(carboxyethylcarbamoyl-4-phenylazo)salicylic Acid

    2. Balsalazide

    3. Balsalazine

    4. Bx 661a

    5. Bx661a

    6. Colazal

    7. Colazide

    2.3.2 Depositor-Supplied Synonyms

    1. Colazal

    2. 213594-60-6

    3. 82101-18-6

    4. Balsalazide Sodium

    5. Colazide

    6. Bx-661a

    7. Balsalazidedisodium

    8. Balsalazide Disodium Anhydrous

    9. 15asw03c9s

    10. Balsalazide Disodium Salt Hydrate

    11. Giazo

    12. Disodium;3-[[4-[(3-carboxy-4-oxidophenyl)diazenyl]benzoyl]amino]propanoate

    13. Balsalazine

    14. Balsalazide Disodium [usan]

    15. Bx 661a

    16. Nsc-760046

    17. Balzide

    18. Balsalazide Disodium Salt

    19. Unii-15asw03c9s

    20. Schembl30360

    21. Schembl3666408

    22. Chembl1200760

    23. Hms2097a22

    24. Hms3264m06

    25. Hms3714a22

    26. Balsalazide Sodium [who-dd]

    27. Akos015896484

    28. Akos025294907

    29. Ccg-213078

    30. Benzoic Acid, 5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-, Disodium Salt

    31. Disodium 5-((4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoate

    32. Disodium 3-[[4-[(2-carboxylatoethylamino)-oxomethyl]phenyl]hydrazinylidene]-6-oxo-1-cyclohexa-1,4-dienecarboxylate

    33. Ft-0622551

    34. Ft-0658348

    35. Balsalazide Disodium Salt Anhydrous [mi]

    36. A815288

    37. J-014008

    38. Q27251713

    39. 5-[4-(2-carboxyethylcarbamoyl)phenylazo]salicylic Acid Disodium Salt

    40. Sodium (e)-5-((4-((2-carboxylatoethyl)carbamoyl)phenyl)diazenyl)-2-hydroxybenzoate

    41. Sodium(e)-5-((4-((2-carboxylatoethyl)carbamoyl)phenyl)diazenyl)-2-hydroxybenzoate

    42. 5-[(1e)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxybenzoic Acid Disodium Salt

    43. Benzoic Acid, 5-((1e)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxy-, Disodium Salt

    44. Benzoic Acid, 5-((1e)-2-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)diazenyl)-2-hydroxy-, Sodium Salt (1:2)

    45. Disodium 3-[[4-[(3-oxidanidyl-3-oxidanylidene-propyl)carbamoyl]phenyl]hydrazinylidene]-6-oxidanylidene-cyclohexa-1,4-diene-1-carboxylate

    46. Disodium,(3z)-3-[[4-(2-carboxylatoethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylate

    2.4 Create Date
    2019-01-15
    3 Chemical and Physical Properties
    Molecular Weight 401.28 g/mol
    Molecular Formula C17H13N3Na2O6
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count6
    Exact Mass401.05997371 g/mol
    Monoisotopic Mass401.05997371 g/mol
    Topological Polar Surface Area154 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity539
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Pharmacology and Biochemistry
    4.1 MeSH Pharmacological Classification

    Gastrointestinal Agents

    Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)

    Anti-Inflammatory Agents, Non-Steroidal

    Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

    4.2 FDA Pharmacological Classification
    4.2.1 Pharmacological Classes
    Aminosalicylic Acids [CS]; Aminosalicylate [EPC]

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    DOSAGE - CAPSULE;ORAL - 750MG

    USFDA APPLICATION NUMBER - 20610

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    DOSAGE - TABLET;ORAL - 1.1GM **Federal Regist...DOSAGE - TABLET;ORAL - 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22205

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    ABOUT THIS PAGE

    Balsalazide Disodium Manufacturers

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

    Balsalazide Disodium Suppliers

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

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

    Balsalazide Disodium USDMF

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

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

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

    Balsalazide Disodium KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Balsalazide Disodium Drug Master File in Korea (Balsalazide Disodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Balsalazide Disodium. The MFDS reviews the Balsalazide Disodium KDMF as part of the drug registration process and uses the information provided in the Balsalazide Disodium KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Balsalazide Disodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Balsalazide Disodium API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Balsalazide Disodium suppliers with KDMF on PharmaCompass.

    Balsalazide Disodium WC

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

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

    Balsalazide Disodium 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 Balsalazide Disodium as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Balsalazide Disodium GMP

    Balsalazide Disodium 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 Balsalazide Disodium 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 Balsalazide Disodium GMP manufacturer or Balsalazide Disodium GMP API supplier for your needs.

    Balsalazide Disodium CoA

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

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

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