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    Chemistry

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    Also known as: 37300-21-3, Pentosan sulfuric polyester, Polypentose sulfate, [(2r,3r,4s,5r)-2-hydroxy-5-[(2s,3r,4s,5r)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] hydrogen sulfate, Xylan, hydrogen sulfate, Unii-f59p8b75r4
    Molecular Formula
    C10H18O21S4
    Molecular Weight
    602.5  g/mol
    InChI Key
    FCCNSUIJIOOXEZ-SJYYZXOBSA-N
    Pentosan Polysulfate Sodium
    A sulfated pentosyl polysaccharide with heparin-like properties.
    1 2D Structure

    Pentosan Polysulfate Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(2R,3R,4S,5R)-2-hydroxy-5-[(2S,3R,4S,5R)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] hydrogen sulfate
    2.1.2 InChI
    InChI=1S/C10H18O21S4/c11-3-1-26-10(8(31-35(22,23)24)5(3)28-32(13,14)15)27-4-2-25-9(12)7(30-34(19,20)21)6(4)29-33(16,17)18/h3-12H,1-2H2,(H,13,14,15)(H,16,17,18)(H,19,20,21)(H,22,23,24)/t3-,4-,5+,6+,7-,8-,9-,10+/m1/s1
    2.1.3 InChI Key
    FCCNSUIJIOOXEZ-SJYYZXOBSA-N
    2.1.4 Canonical SMILES
    C1C(C(C(C(O1)OC2COC(C(C2OS(=O)(=O)O)OS(=O)(=O)O)O)OS(=O)(=O)O)OS(=O)(=O)O)O
    2.1.5 Isomeric SMILES
    C1[C@H]([C@@H]([C@H]([C@@H](O1)O[C@@H]2CO[C@H]([C@@H]([C@H]2OS(=O)(=O)O)OS(=O)(=O)O)O)OS(=O)(=O)O)OS(=O)(=O)O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Bay 946

    2. Bay-946

    3. Elmiron

    4. Fibrocid

    5. Hemoclar

    6. Hoe 946

    7. Hoe Bay 946

    8. Hoe-946

    9. Hoe-bay 946

    10. Hoe-bay-946

    11. Pentosan Polysulfate Sodium

    12. Pentosan Polysulphate Sodium

    13. Pentosan Sulfuric Polyester

    14. Pentosane Sulfuric Polyester

    15. Polyester, Pentosan Sulfuric

    16. Polyester, Pentosane Sulfuric

    17. Polypentose Sulfate

    18. Polysulfate Sodium, Pentosan

    19. Polysulfate, Pentosan

    20. Polysulfated Xylan

    21. Polysulphate Sodium, Pentosan

    22. Pz 68

    23. Pz-68

    24. Pz68

    25. Sodium, Pentosan Polysulfate

    26. Sodium, Pentosan Polysulphate

    27. Sp 54

    28. Sp 54, Tavan

    29. Sp-54

    30. Sp54

    31. Sp54, Xylan

    32. Sulfate, Polypentose

    33. Sulfate, Xylan

    34. Sulfuric Polyester, Pentosan

    35. Sulfuric Polyester, Pentosane

    36. Tavan Sp 54

    37. Xylan Sp54

    38. Xylan Sulfate

    39. Xylan, Polysulfated

    2.2.2 Depositor-Supplied Synonyms

    1. 37300-21-3

    2. Pentosan Sulfuric Polyester

    3. Polypentose Sulfate

    4. [(2r,3r,4s,5r)-2-hydroxy-5-[(2s,3r,4s,5r)-5-hydroxy-3,4-disulfooxyoxan-2-yl]oxy-3-sulfooxyoxan-4-yl] Hydrogen Sulfate

    5. Xylan, Hydrogen Sulfate

    6. Unii-f59p8b75r4

    7. Schembl157354

    8. Chembl4073796

    9. Chebi:184555

    10. F59p8b75r4

    11. Db00686

    12. Q7165276

    13. [(2r,3r,4s,5r)-2-hydroxy-5-[(2s,3r,4s,5r)-5-hydroxy-3,4-disulooxyoxan-2-yl]oxy-3-sulooxyoxan-4-yl] Hydrogen Sulate

    14. [(2r,3r,4s,5r)-2-hydroxy-5-{[(2s,3r,4s,5r)-5-hydroxy-3,4-bis(sulfooxy)oxan-2-yl]oxy}-4-(sulfooxy)oxan-3-yl]oxidanesulfonic Acid

    15. [(2s,3r,4s,5r)-5-hydroxy-2-{[(3r,4s,5r,6r)-6-hydroxy-4,5-bis(sulfooxy)oxan-3-yl]oxy}-4-(sulfooxy)oxan-3-yl]oxidanesulfonic Acid

    16. 11096-31-4

    2.3 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 602.5 g/mol
    Molecular Formula C10H18O21S4
    XLogP3-5.6
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count21
    Rotatable Bond Count10
    Exact Mass601.92234227 g/mol
    Monoisotopic Mass601.92234227 g/mol
    Topological Polar Surface Area356 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity1140
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameElmiron
    PubMed HealthPentosan Polysulfate Sodium (By mouth)
    Drug ClassesCystitis Agent, Urinary Stone Agent
    Drug LabelPentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water...
    Active IngredientPentosan polysulfate sodium
    Dosage FormCapsule
    RouteOral
    Strength100mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 2  
    Drug NameElmiron
    PubMed HealthPentosan Polysulfate Sodium (By mouth)
    Drug ClassesCystitis Agent, Urinary Stone Agent
    Drug LabelPentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water...
    Active IngredientPentosan polysulfate sodium
    Dosage FormCapsule
    RouteOral
    Strength100mg
    Market StatusPrescription
    CompanyJanssen Pharms

    4.2 Drug Indication

    For the relief of bladder pain or discomfort associated with interstitial cystitis.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Pentosan polysulfate sodium is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects.

    5.2 MeSH Pharmacological Classification

    Anticoagulants

    Agents that prevent BLOOD CLOTTING. (See all compounds classified as Anticoagulants.)

    5.3 Absorption, Distribution and Excretion

    Absorption

    Slow

    5.4 Biological Half-Life

    4.8 hours

    5.5 Mechanism of Action

    Pentosan polysulfate is a polymer of xylose hydrogen sulfate and contains two sulfate groups per carbohydrate monomer. It binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors. It has been shown to interact also with the heparin-binding site of FGFR-1. It inhibits the growth of SW13 adrenocortical cells transfected with FGF-4 and tumorigenicity of MCF-7 breast carcinoma cells transfected with FGF-1 or FGF-4.

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NO.37","city":"BOMBAY ,MAHARASHTRA","supplier":"TRICON ENTERPRISES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"A.L.S.A","customerCountry":"SPAIN","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"2725","totalValueFC":"32034.9","currency":"USD","unitRateINR":226830.95583333334,"date":"04-Dec-2024","totalValueINR":"2721971.47","totalValueInUsd":"32034.9","indian_port":"Madras Air","hs_no":"29339990","bill_no":"6171398","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"KAMALA BHUVAN NO.2, 1ST FLR. NO.37, BOMBAY ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733250600,"product":"PENTOSAN POLYSULFATE SODIUM-BCH NO:EPPS2403003 MFGDT MAR 2024 RETEST DT FEB 2027","address":"KAMALA BHUVAN NO.2, 1ST FLR. 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VAISHNODE","city":"AHMEDABAD","supplier":"ITALFARMACO S.P.A","supplierCountry":"ITALY","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"1.30","actualQuantity":"1.3","unit":"KGS","unitRateFc":"3900","totalValueFC":"5408.8","currency":"EUR","unitRateINR":"321555","date":"19-May-2022","totalValueINR":"418021.5","totalValueInUsd":"5408.8","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"8741456","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1653589800,"product":"FV0973 PPS HD ( PENTOSAN POLYSULFATE SODIUM ) LOT NO. 22P0471.","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ITALFARMACO S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"13.00","actualQuantity":"13","unit":"KGS","unitRateFc":"4062.6","totalValueFC":"53712","currency":"USD","unitRateINR":"319320.9","date":"27-May-2022","totalValueINR":"4151172","totalValueInUsd":"53712","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1002126","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA DEI LAVORATORI 54 20092 CINISEL LO BALSAMO (MI) ITALY 0","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1660156200,"product":"PPS HD PENTOSAN POLYSULFATE SODIUM. 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    14-Jan-2021
    04-Dec-2024
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    ABOUT THIS PAGE

    Pentosan Sulfuric Polyester Manufacturers

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

    Pentosan Sulfuric Polyester Suppliers

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

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

    Pentosan Sulfuric Polyester USDMF

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

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

    click here to find a list of Pentosan Sulfuric Polyester suppliers with USDMF on PharmaCompass.

    Pentosan Sulfuric Polyester KDMF

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

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

    After submitting a Pentosan Sulfuric Polyester 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 Pentosan Sulfuric Polyester API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Pentosan Sulfuric Polyester suppliers with KDMF on PharmaCompass.

    Pentosan Sulfuric Polyester WC

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

    click here to find a list of Pentosan Sulfuric Polyester suppliers with Written Confirmation (WC) on PharmaCompass.

    Pentosan Sulfuric Polyester 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 Pentosan Sulfuric Polyester as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Pentosan Sulfuric Polyester suppliers with NDC on PharmaCompass.

    Pentosan Sulfuric Polyester GMP

    Pentosan Sulfuric Polyester 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 Pentosan Sulfuric Polyester 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 Pentosan Sulfuric Polyester GMP manufacturer or Pentosan Sulfuric Polyester GMP API supplier for your needs.

    Pentosan Sulfuric Polyester CoA

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

    Pentosan Sulfuric Polyester CoA mostly includes findings from lab analyses of a specific batch. For each Pentosan Sulfuric Polyester 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.

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