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    Also known as: 25655-41-8, Povidone-iodine, Betadine, Isodine, Pvp iodine, Pvp-iodine
    Molecular Formula
    C6H9I2NO
    Molecular Weight
    364.95  g/mol
    InChI Key
    CPKVUHPKYQGHMW-UHFFFAOYSA-N
    Povidone Iodine
    An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.
    1 2D Structure

    Povidone Iodine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-ethenylpyrrolidin-2-one;molecular iodine
    2.1.2 InChI
    InChI=1S/C6H9NO.I2/c1-2-7-5-3-4-6(7)8;1-2/h2H,1,3-5H2;
    2.1.3 InChI Key
    CPKVUHPKYQGHMW-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C=CN1CCCC1=O.II
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Alphadine

    2. Alphadines

    3. Betadine

    4. Betadines

    5. Betaisodona

    6. Disadine

    7. Disadines

    8. Isodine

    9. Isodines

    10. Pharmadine

    11. Pharmadines

    12. Polyvinylpyrrolidone Iodine

    13. Polyvinylpyrrolidone Iodines

    14. Povidone-iodine

    15. Povidone-iodines

    16. Providine

    17. Providines

    18. Pvp Iodine

    19. Pvp-i

    20. Pvp-iodine

    21. Pvp-iodines

    2.2.2 Depositor-Supplied Synonyms

    1. 25655-41-8

    2. Povidone-iodine

    3. Betadine

    4. Isodine

    5. Pvp Iodine

    6. Pvp-iodine

    7. Pvp-i

    8. Isobetadyne

    9. Bridine

    10. Disphex

    11. Povadyne

    12. Ultradine

    13. Efo-dine

    14. Iodopoly(vinyl Pyrrolidinone)

    15. 1-ethenylpyrrolidin-2-one;molecular Iodine

    16. Nsc26245

    17. 2-pyrrolidinone, 1-ethenyl-, Homopolymer, Compd. With Iodineother Ca Index Names:iodine, Compd. With 1-ethenyl-2-pyrrolidinone Homopolymer

    18. Iodine-poly(vinylpyrrolidinone)

    19. Poly(vinylpyrrolidinone) Iodide

    20. Iodinated Poly(vinylpyrrolidone)

    21. Poly(vinylpyrrolidone)-iodine Adduct

    22. Poly(vinylpyrrolidinone)-iodine Complex

    23. Poly(vinylpyrrolidone) - Iodine Complex

    24. Polyvinylpyrrolidone Compound With Iodine

    25. Povidone.iodine

    26. 1-ethenyl-2-pyrrolidinone Homopolymer Compound With Iodine

    27. Molecular Iodine; 1-vinylpyrrolidin-2-one

    28. 1-ethenylpyrrolidin-2-one; Molecular Iodine

    29. Povidone Iodine-ip, 9-12%

    30. Schembl1652685

    31. Bcp28568

    32. Nsc28655

    33. Mfcd00084483

    34. Nsc-26245

    35. Nsc-28655

    36. Akos015898248

    37. Polyvinylpyrrolidone-iodinecomplex

    38. 1-ethenyl-2-pyrrolidinone; Molecular Iodine

    39. Ft-0655804

    40. 2-pyrrolidinone, Polymers, Compd. With Iodine

    41. A16118

    42. 2-pyrrolidinone, Homopolymer, Compd. With Iodine

    43. A817952

    44. Q241516

    45. 1-vinylpyrrolidin-2-one Compound With Diiodine (1:1)

    46. Poly[1-(2-oxo-1-pyrrolidinyl)ethylene]iodine Complex

    47. Povidone (iodinated), European Pharmacopoeia (ep) Reference Standard

    2.3 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 364.95 g/mol
    Molecular Formula C6H9I2NO
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count1
    Exact Mass364.87736 g/mol
    Monoisotopic Mass364.87736 g/mol
    Topological Polar Surface Area20.3 Ų
    Heavy Atom Count10
    Formal Charge0
    Complexity120
    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 4  
    Drug NameBetadine
    PubMed HealthPovidone Iodine (Into the eye)
    Drug ClassesAntiseptic
    Drug LabelPovidone-Iodine is a broad-spectrum microbicide with the chemical formulas:2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:BETADINE 5% Ster...
    Active IngredientPovidone-iodine
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength5%
    Market StatusPrescription
    CompanyAlcon Pharms

    2 of 4  
    Drug NamePovidone iodine
    PubMed HealthPovidone Iodine (Into the eye)
    Drug ClassesAntiseptic
    Drug LabelOther InformationStore below 98F/37C avoid direct heat and sunlight...
    Active IngredientPovidone-iodine
    Dosage FormSolution
    RouteTopical
    Strength1%
    Market StatusOver the Counter
    CompanyAllegiance Hlthcare

    3 of 4  
    Drug NameBetadine
    PubMed HealthPovidone Iodine (Into the eye)
    Drug ClassesAntiseptic
    Drug LabelPovidone-Iodine is a broad-spectrum microbicide with the chemical formulas:2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:BETADINE 5% Ster...
    Active IngredientPovidone-iodine
    Dosage FormSolution/drops
    RouteOphthalmic
    Strength5%
    Market StatusPrescription
    CompanyAlcon Pharms

    4 of 4  
    Drug NamePovidone iodine
    PubMed HealthPovidone Iodine (Into the eye)
    Drug ClassesAntiseptic
    Drug LabelOther InformationStore below 98F/37C avoid direct heat and sunlight...
    Active IngredientPovidone-iodine
    Dosage FormSolution
    RouteTopical
    Strength1%
    Market StatusOver the Counter
    CompanyAllegiance Hlthcare

    4.2 Therapeutic Uses

    Anti-Infective Agents, Local

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2014)

    Povidone-iodine is an iodophore that is used as a disinfectant and antiseptic mainly for the treatment of contaminated wounds and pre-operative preparation of the skin and mucous membranes as well as for disinfection of equipment.

    SWEETMAN, S.C. (ed.) Martindale-The Complete Drug Reference. 36th ed. London: The Pharmaceutical Press, 2009., p. 1659

    BETADINE 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).

    NIH; DailyMed. Current Medication Information for BETADINE- povidone-iodine solution (Revised: July 2011). Available from, as of October 14, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b026de1b-9949-4557-ac49-c7b0038c24cd

    4.3 Drug Warning

    No studies are available in patients with thyroid disorders; therefore, caution is advised in using BETADINE 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption.

    NIH; DailyMed. Current Medication Information for BETADINE- povidone-iodine solution (Revised: July 2011). Available from, as of October 14, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b026de1b-9949-4557-ac49-c7b0038c24cd

    Because of the potential for serious adverse reactions in nursing infants from BETADINE 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

    NIH; DailyMed. Current Medication Information for BETADINE- povidone-iodine solution (Revised: July 2011). Available from, as of October 14, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b026de1b-9949-4557-ac49-c7b0038c24cd

    FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

    NIH; DailyMed. Current Medication Information for BETADINE- povidone-iodine solution (Revised: July 2011). Available from, as of October 14, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b026de1b-9949-4557-ac49-c7b0038c24cd

    For external use only. Not for intraocular injection or irrigation.

    NIH; DailyMed. Current Medication Information for BETADINE- povidone-iodine solution (Revised: July 2011). Available from, as of October 14, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b026de1b-9949-4557-ac49-c7b0038c24cd

    For more Drug Warnings (Complete) data for Povidone-iodine (9 total), please visit the HSDB record page.

    4.4 Drug Indication

    For topical application in the treatment and prevention of infection in wounds.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Povidone iodine is a kind of iodine disinfectant which directly cause in vivo protein denaturation, precipitation of bacteria, and further resulting in the death of pathogenic microorganisms. Therefore, it is effective in disinfection and sterilization. It can kill viruses, bacteria, spores, fungi, and protozoa with low toxicity to human. Povidone-iodine aqueous solution has strong pharmacological activity against Staphylococcus aureus, Neisseria gonorrhoeae, Pseudomonas aeruginosa, syphilis, hepatitis B virus, HIV, and Trichomonas vaginalis. Povidone iodine gel is a gynecological topical semi-mobile colloidal agent made by povidone iodine and hydrophilic matrix. It is a system for maintaining its sustained release. Owing to the continuous release of free iodine, it can enable the skin and mucous membranes to maintain a certain effective concentration of iodine for killing bacteria. It is mainly used for gynecological vaginal infection. It exerted its effect through being miscible with vaginal secretions and further killing the inside pathogenic microorganisms, and thus blocking the spread of sexually transmitted diseases and invasion, as well as treating other infected vaginal diseases caused by other kinds of bacteria. Published reports on the in vitro antimicrobial efficacy of iodophors demonstrate that iodophors are bactericidal, mycobactericidal, and virucidal but can require prolonged contact times to kill certain fungi and bacterial spores. Three brands of povidone-iodine solution have demonstrated more rapid kill (seconds to minutes) of S. aureus and M. chelonae at a 1:100 dilution than did the stock solution. The virucidal activity of 75150 ppm available iodine was demonstrated against seven viruses. Other investigators have questioned the efficacy of iodophors against poliovirus in the presence of organic matter and rotavirus in distilled or tapwater. Manufacturers' data demonstrate that commercial iodophors are not sporicidal, but they are tuberculocidal, fungicidal, virucidal, and bactericidal at their recommended use-dilution.

    5.2 MeSH Pharmacological Classification

    Anti-Infective Agents, Local

    Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects. (See all compounds classified as Anti-Infective Agents, Local.)

    5.3 ATC Code

    D - Dermatologicals

    D08 - Antiseptics and disinfectants

    D08A - Antiseptics and disinfectants

    D08AG - Iodine products

    D08AG02 - Povidone-iodine

    D - Dermatologicals

    D09 - Medicated dressings

    D09A - Medicated dressings

    D09AA - Medicated dressings with antiinfectives

    D09AA09 - Povidone-iodine

    D - Dermatologicals

    D11 - Other dermatological preparations

    D11A - Other dermatological preparations

    D11AC - Medicated shampoos

    D11AC06 - Povidone-iodine

    G - Genito urinary system and sex hormones

    G01 - Gynecological antiinfectives and antiseptics

    G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

    G01AX - Other antiinfectives and antiseptics

    G01AX11 - Povidone-iodine

    R - Respiratory system

    R02 - Throat preparations

    R02A - Throat preparations

    R02AA - Antiseptics

    R02AA15 - Povidone-iodine

    S - Sensory organs

    S01 - Ophthalmologicals

    S01A - Antiinfectives

    S01AX - Other antiinfectives

    S01AX18 - Povidone-iodine

    5.4 Absorption, Distribution and Excretion

    Absorption

    Povidone-Iodine is intended for topical application and is not absorbed.

    Route of Elimination

    Povidone-Iodine is intended for topical application and is not eliminated.

    Volume of Distribution

    Povidone-Iodine is intended for topical application and has no volume of distribution.

    Clearance

    Povidone-Iodine is intended for topical application and is not eliminated.

    Topical application of povidone iodine on the umbilical cord and normal intact skin of newborn infants resulted in significantly elevated plasma iodine levels. High iodine levels were also found in two neonates who had povidone iodine applied to denuded skin. No significant alteration in thyroid function was seen. The possible toxic manifestations of high plasma iodine levels are discussed.

    PMID:909027 Pyati SP et al; J Pediatr. 91 (5): 825-8 (1977)

    In 12 nonpregnant women, total iodine, protein-bound iodine, inorganic iodine, and thyroxine values were measured in serum before and 15, 30, 45 or 60 minutes after a two-minute vaginal disinfection with povidone-iodine (Betadine). Only 15 minutes after application, serum iodine levels were raised and remained significantly elevated 30, 45 and 60 minutes after disinfection. Serum concentrations of total iodine and inorganic iodine were increased up to fivefold to 15-fold, respectively; during the relative short period of observation, thyroxine levels were not altered.

    PMID:7431610 Vorherr H et al; JAMA. 244 (23): 2628-9 (1980)

    5.5 Metabolism/Metabolites

    Povidone-Iodine is not absorbed or metabolized.

    5.6 Biological Half-Life

    Povidone-Iodine is intended for topical application and is not eliminated.

    5.7 Mechanism of Action

    Povidone-iodine is called iodophore which means povidone acts as a carrier of iodine. Iodine is considered as the active moiety that mediates microbicidal actions. When released from the complex, free iodine (I2) penetrates the cell wall of microorganisms quickly, and the lethal effects are believed to result from disruption of protein and nucleic acid structure and synthesis. While the full mechanism of action is not fully elucidated, iodine is thought to inhibit vital bacterial cellular mechanisms and structures, and oxidizes nucleotides fatty or amino acids in bacterial cell membranes. Additionally, free iodine disrupts the function of the cytosolic enzymes involved in the respiratory chain, causing them to become denatured and deactivated. _In vitro_ evidence suggests that iodine also counteracts inflammation elicited by both pathogens and the host response via multifactorial effects. In hosts, povidone-iodine was demonstrated to modulate the redox potential, inhibit the release of inflammatory mediators such as TNF- and -galactosidase, inhibit metalloproteinase production, and potentiate the healing signals from pro-inflammatory cytokines by activation of monocytes, T-lymphocytes, and macrophages, _in vitro_.

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    05-Jan-2021
    31-Mar-2025
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    ABOUT THIS PAGE

    Looking for 25655-41-8 / Povidone-Iodine API manufacturers, exporters & distributors?

    Povidone-Iodine manufacturers, exporters & distributors 1

    23

    PharmaCompass offers a list of Povidone-Iodine 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 Povidone-Iodine manufacturer or Povidone-Iodine supplier for your needs.

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

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

    API | Excipient name

    Povidone-Iodine

    Synonyms

    25655-41-8, Betadine, Isodine, Pvp iodine, Pvp-iodine, Pvp-i

    Cas Number

    25655-41-8

    About Povidone-Iodine

    An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.

    Isodine Manufacturers

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

    Isodine Suppliers

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

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

    Isodine USDMF

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

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

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

    Isodine JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Isodine Drug Master File in Japan (Isodine JDMF) empowers Isodine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Isodine JDMF during the approval evaluation for pharmaceutical products. At the time of Isodine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Isodine suppliers with JDMF on PharmaCompass.

    Isodine CEP

    A Isodine CEP of the European Pharmacopoeia monograph is often referred to as a Isodine Certificate of Suitability (COS). The purpose of a Isodine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isodine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isodine to their clients by showing that a Isodine CEP has been issued for it. The manufacturer submits a Isodine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isodine CEP holder for the record. Additionally, the data presented in the Isodine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isodine DMF.

    A Isodine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isodine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Isodine suppliers with CEP (COS) on PharmaCompass.

    Isodine WC

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

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

    Isodine 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 Isodine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Isodine GMP

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

    Isodine CoA

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

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

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