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Povidone-iodine | CAS No: 25655-41-8 | GMP-certified suppliers
A medication that supports reliable prevention and treatment of wound and gynecologic infections through broad topical antimicrobial action used across surgical, dermatologic, and gynecologic care.
Therapeutic categories
Primary indications
- For topical application in the treatment and prevention of infection in wounds
Product Snapshot
- Topical antiseptic available in multiple cutaneous and mucosal formulations such as liquids, solutions, gels, ointments, swabs, sprays, and related kit presentations
- Used for prevention and management of wound contamination and surface microbial burden
- Approved and marketed in the US and Canada
Clinical Overview
Its pharmacological activity derives from the controlled liberation of free iodine, which rapidly penetrates microbial cell walls. The antimicrobial effect is attributed to oxidative disruption and denaturation of proteins, nucleotides, and membrane components, leading to loss of structural integrity and cell death. Povidone‑iodine demonstrates broad in vitro activity against bacteria, viruses, fungi, protozoa, and mycobacteria. Although effective against many pathogens, longer contact times may be required for fungal species and bacterial spores, and published data note variable performance in the presence of organic material.
The mechanism of action is not fully resolved, but free iodine is known to disrupt respiratory chain enzymes and interfere with nucleic acid and protein synthesis. In vitro evidence also suggests ancillary anti‑inflammatory effects through modulation of redox pathways and inhibition of select cytokines and matrix‑degrading enzymes.
Absorption through intact skin is low, though systemic iodine uptake can increase with extensive or repeated application, especially on compromised skin or mucosa. Excessive exposure may affect thyroid function, particularly in neonates or patients with pre‑existing thyroid disease. Local irritation is possible, and ocular tissues are sensitive to concentrated solutions.
Common usage contexts include preoperative skin preparation, wound cleansing, and gynecologic antisepsis, with numerous commercial solutions, scrubs, and gels available internationally.
For API procurement, suppliers should provide clear specifications for available iodine content, impurity profile, polymer characteristics, and microbial quality. Control of iodine release properties and polymer stability is essential for consistent formulation performance.
Identification & chemistry
| Generic name | Povidone-iodine |
|---|---|
| Molecule type | Small molecule |
| CAS | 25655-41-8 |
| UNII | 85H0HZU99M |
| DrugBank ID | DB06812 |
Pharmacology
| Summary | Povidone‑iodine is an iodophore that delivers free iodine, which penetrates microbial cells and disrupts proteins, nucleic acids, and membrane components, producing broad-spectrum microbicidal activity. Its pharmacodynamic effect reflects sustained iodine release, enabling activity against bacteria, viruses, fungi, protozoa, and mycobacteria. In vitro findings also suggest ancillary modulation of inflammatory pathways through redox effects and altered cytokine and enzyme activity. |
|---|---|
| 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-α and β-galactosidase, inhibit metalloproteinase production, and potentiate the healing signals from pro-inflammatory cytokines by activation of monocytes, T-lymphocytes, and macrophages, _in vitro_ . |
| Pharmacodynamics | 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 75–150 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. |
ADME / PK
| Absorption | Povidone-Iodine is intended for topical application and is not absorbed. |
|---|---|
| Half-life | Povidone-Iodine is intended for topical application and is not eliminated. |
| Protein binding | To be used topical. No plasma protein binding reported. |
| Metabolism | Povidone-Iodine is not absorbed or metabolized. |
| 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. |
Formulation & handling
- Primarily formulated as topical antiseptic solutions, gels, and ointments; aqueous systems must maintain sufficient free iodine while controlling pH to balance stability and antimicrobial activity.
- Iodine release is sensitive to light, heat, and organic load, so packaging often uses amber containers and formulations may include stabilizers to limit iodine depletion and polymer degradation.
- Not typically used systemically; inadvertent systemic exposure (oral, ophthalmic, inhalation) requires attention to iodine load and excipient compatibility because povidone–iodine can interact with metals, proteins, and reducing agents.
Regulatory status
| Lifecycle | Most U.S. patents for this API expire between 2023 and 2027, indicating that the product is moving from mid‑ to late‑lifecycle status. With commercialization limited to the US and Canada, market maturity will increase as remaining protections lapse. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Povidone‑iodine is supplied by multiple established manufacturers, with originator activity primarily related to specific formulations or delivery systems rather than the core antiseptic API. Branded products are widely available in the US and Canada, reflecting broad global use of this mature ingredient. Several listed US patents expire between 2023 and 2027, indicating that formulation‑level protections are ending and generic or alternative presentations are already well established. |
|---|
Safety
| Toxicity | ORAL (LD50): Acute: 8000 mg/kg [Rat]. 8100 mg/kg [Mouse] |
|---|
- High oral LD50 values in rodents (approx
- 8000–8100 mg/kg) indicate low acute oral toxicity, but ingestion should still be avoided in manufacturing environments
- Dust or aerosol generation should be minimized to prevent unintended exposure, as systemic effects at elevated doses are possible
Povidone-iodine is a type of Disinfectants
Disinfectants are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a vital role in maintaining cleanliness and preventing the spread of harmful microorganisms. These chemical agents are designed to eliminate or inhibit the growth of bacteria, viruses, fungi, and other pathogens on various surfaces and objects.
Pharmaceutical-grade disinfectants are formulated to meet stringent quality standards and are commonly used in hospitals, laboratories, pharmaceutical manufacturing facilities, and other healthcare settings. They are also utilized in the food and beverage industry, as well as in households, to ensure proper sanitation and hygiene.
Disinfectants typically contain active ingredients such as quaternary ammonium compounds, chlorine compounds, hydrogen peroxide, or alcohol, which have been proven effective against a broad spectrum of microorganisms. These active ingredients work by disrupting the cell membranes or enzymatic processes of the pathogens, rendering them incapable of replication and causing their eventual destruction.
When selecting a disinfectant, factors such as the intended application, target microorganisms, and compatibility with the surfaces or objects being treated need to be considered. It is crucial to follow proper usage instructions and adhere to recommended contact times for effective disinfection.
In conclusion, disinfectants are essential pharmaceutical APIs used to control and prevent the spread of harmful microorganisms. Their efficacy in eliminating pathogens makes them indispensable in maintaining cleanliness and ensuring public health and safety.
Povidone-iodine (Disinfectants), classified under Antidotes, Deterrents, and Toxicologic Agents
Antidotes, Deterrents, and Toxicologic Agents are an important category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a critical role in healthcare and toxicology. These substances are designed to counteract the effects of poisons, toxins, and overdoses, thereby saving lives and preventing severe health consequences.
Antidotes are substances that neutralize the toxic effects of certain drugs, chemicals, or poisons. They work by either directly binding to the toxic substance or by blocking its harmful actions on the body. Antidotes are administered in emergency situations to quickly reverse the effects of poisoning and restore normal physiological functions.
Deterrents, on the other hand, are pharmaceutical agents used to discourage or prevent harmful behaviors, such as substance abuse. They are designed to make the ingestion or misuse of certain substances unpleasant or less desirable. Deterrents can be formulated to cause unpleasant side effects, such as nausea or vomiting, when a particular substance is consumed in excessive amounts.
Toxicologic agents encompass a broad range of pharmaceutical APIs used in toxicology studies and research. These substances are employed to investigate the toxicity, metabolism, and mechanisms of action of various chemicals and compounds. Toxicologic agents are vital for understanding the potential hazards and risks associated with certain substances, ensuring the safety of drugs, and developing effective treatments for poisoning cases.
In conclusion, Antidotes, Deterrents, and Toxicologic Agents are essential categories of pharmaceutical APIs that address poisoning emergencies, deter harmful behaviors, and enable toxicological research. Their development and availability are crucial for safeguarding public health, enhancing patient care, and advancing our understanding of toxicology.
Povidone-iodine API manufacturers & distributors
Compare qualified Povidone-iodine API suppliers worldwide. We currently have 15 companies offering Povidone-iodine API, with manufacturing taking place in 7 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Ashland Industries | Producer | Switzerland | Switzerland | CEP, CoA | 9 products |
| BASF | Producer | Germany | Unknown | CEP, CoA, FDA, GMP, USDMF | 18 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Marcus Research Lab | Producer | United States | United States | CoA, USDMF | 1 products |
| Nanz Med Science Pharma | Producer | India | India | CoA, WC | 1 products |
| Pharm Rx Chemical Corp | Distributor | United States | United States | CoA, FDA, GMP | 166 products |
| Prachi Pharmaceuticals | Producer | India | India | CoA, GMP, WC | 12 products |
| Proto Chemical Industries | Producer | India | India | CoA, USDMF | 2 products |
| R.N. Laboratories | Producer | India | India | CoA, USDMF | 2 products |
| Shaanxi Dasheng Pharma | Producer | China | China | CoA, WC | 3 products |
| Shanghai Yuking | Producer | China | China | CoA, USDMF | 1 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 757 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| The Graymor Chemical | Producer | Germany | Germany | CEP, CoA | 1 products |
When sending a request, specify which Povidone-iodine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Povidone-iodine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Povidone-iodine API
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Technical
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Regulatory
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Pharmaoffer
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