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Povidone-Iodine (Isodine Betadine) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    • Product Name: Povidone-Iodine (Isodine Betadine) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions
    • Factroy Site: Yudu County, Ganzhou, Jiangxi, China
    • Price Inquiry: sales10@sinochem-nanjing.com
    • Manufacturer: Ascent Petrochem Holdings Co., Limited
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    VTB
    Specifications
    HS Code 381349
    Productname Povidone-Iodine (Isodine/Betadine) Veterinary Grade API
    Synonyms PVP-I; Polyvinylpyrrolidone-iodine; Isodine; Betadine
    Chemicalname Polyvinylpyrrolidone-iodine complex
    Casnumber 25655-41-8
    Molecularformula (C6H9NO)n·xI2
    Molecularweight Variable; typically expressed as available iodine content
    Appearance Brown to reddish-brown amorphous powder; solutions are dark brown
    Odor Faint characteristic iodine odor
    Availableiodinecontent 9.0%–12.0% w/w; typical 10%
    Iodidecontent ≤6.0%
    Lossondrying ≤8.0%
    Heavymetals ≤20 ppm
    Ph 1.5–5.0 for a 10% aqueous solution
    Solubility Soluble in water and ethanol; practically insoluble in acetone, ether, and chloroform
    Assay 99.0%–101.0% of labeled available iodine content
    Microbiallimits Total aerobic microbial count ≤1000 CFU/g; total yeast and mold count ≤100 CFU/g; absence of E. coli, Salmonella, S. aureus, and P. aeruginosa
    Veterinarygrade Veterinary grade active pharmaceutical ingredient
    Dosageforms Tablets, injections, capsules, powders, granules, premix, solutions
    Veterinaryindications Antiseptic and disinfectant for skin, wounds, navels, udders, teats, hooves, oral cavity, uterus, and environmental surfaces in livestock, poultry, horses, dogs, and cats
    Routesofadministration Topical, oral, intramammary, intrauterine, drinking water, spray, dip, and injection where approved
    Storageconditions Store in tightly closed containers, protected from light, in a cool and dry place
    Shelflife Typically 24–36 months in unopened original packaging
    Packaging Fiber drums, plastic drums, foil bags, or as per customer specification

    As an accredited Povidone-Iodine (Isodine Betadine) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing 25 kg sealed, moisture-barrier drums with double liners, suitable for veterinary-grade povidone-iodine API tablets, injections, capsules, powders, granules, premix, solutions.
    Container Loading (20′ FCL) Container Loading (20′ FCL): palletized, sealed drums of veterinary-grade Povidone-Iodine API, dry-stowed for tablets, injections, capsules, powders, granules, premix, solutions.
    Shipping Povidone-iodine veterinary-grade API, in tablets, injections, capsules, powders, granules, premix, or solutions, ships in sealed, light-resistant containers at ambient temperature, protected from moisture and heat. Generally non-hazardous for transport unless regulations specify otherwise. Include MSDS, CoA, batch/lot records, and compliant labeling. All shipments meet applicable local, national, and international veterinary pharmaceutical shipping requirements.
    Storage Store in a cool, dry, well-ventilated area below 30°C, away from direct sunlight, heat, and moisture. Keep containers tightly closed, protected from light, and clearly labeled. Segregate from food, feed, and incompatible chemicals. Use appropriate PPE, follow veterinary API handling guidelines, maintain spill containment, and prevent contamination during dispensing, repackaging, or formulation. Store in original packaging. Avoid excessive stacking.
    Shelf Life Povidone-iodine veterinary API typically has a 2–3 year shelf life when sealed, stored cool, dry, protected from light; confirm per dosage form.
    Application of Povidone-Iodine (Isodine Betadine) Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions

    In dairy herd mastitis control, the iodophor's free iodine release kinetics in an emollient teat-dip formulation are governed by pH buffering and temperature-dependent dissociation of the polyvinylpyrrolidone-iodine complex. Commercially, a 10% w/w povidone-iodine stock is diluted with deionized water and glycerin or sorbitol emollients to a final available iodine concentration of 0.25–0.5% for pre-milking and 0.5–1.0% for post-milking barrier dips, as specified in National Mastitis Council (NMC) recommended protocols and EU Biocidal Products Regulation (EU) No 528/2012 for product-type 3 veterinary hygiene. The mixing vessel, typically a 316L stainless steel agitated tank with a specific power input of 1.5–3.0 kW/1,000 L, is cleaned by clean-in-place procedures before and after each batch to prevent anionic surfactant carryover, which depresses free iodine availability. pH is adjusted to 4.5–5.5 with citric acid or sodium phosphate because free iodine activity drops steeply above pH 6.0; acid adjustment precedes PVP-I addition to avoid local precipitation. Blending is followed by 150 μm nominal filtration and filling into opaque high-density polyethylene drums or jumbo containers that pass iodine permeability testing under 40 °C accelerated storage. Terminal product classes include pre-dip, post-dip, foaming udder wash, and winterized barrier dip containing 2–5% film-forming polyvinyl alcohol or xanthan gum; the barrier film is evaluated for iodine retention and film integrity after a 10-minute water rinse, and bactericidal activity is confirmed by EN 1040 suspension testing with hard water dilution.

    Why Does Contact Time Limit PVP-I Efficacy in Hatchery Egg Sanitization?

    In commercial broiler and layer hatcheries, egg surface sanitization with povidone-iodine must respond to the cuticle's hydrophobic surface and the risk of pulling contaminated water through shell pores during temperature differential shifts. The standard procedure immerses clean hatching eggs at 35–40 °C in a 50–100 mg/L available iodine solution for 10 minutes, with the water bath held 2–3 °C above egg temperature to prevent pressure-driven ingress of bacteria; this window is referenced in hatchery biosecurity manuals and EU 528/2012 product-type 3 authorisations. Stainless steel immersion tanks are equipped with recirculating pumps and iodine-specific oxidation-reduction potential sensors, because organic load from egg debris consumes free iodine; oxidation-reduction potential is maintained above 650 mV versus Ag/AgCl. Solution replacement frequency is determined by iodometric titration with 0.1 N sodium thiosulfate rather than fixed egg counts, with replacement triggered when measured available iodine falls below 70% of initial titre. Terminal products supplied to hatcheries include 10% PVP-I concentrates, ready-to-use 1% solutions, and aerosol mists for cabinet sanitation; the API lot used for these products must pass the USP Povidone-Iodine Topical Solution monograph assays for total and available iodine and comply with 21 CFR Part 211 if exported into the United States market. Incompatibility with sodium thiosulfate neutralising solutions and alkaline detergent residues is controlled by separate dedicated dosing lines and final rinse verification.

    Comparative compliance and dosing parameters for major PVP-I veterinary downstream routes
    Downstream segmentTarget available iodine / addition levelPrimary standard or regulatory codeTerminal product classes
    Dairy cattle teat hygiene0.25–0.5% pre-dip; 0.5–1.0% post-dipNMC protocols, EU 528/2012 PT3, EN 1040Pre-dip, post-dip, udder wash, barrier dip
    Poultry hatchery egg sanitization50–100 mg/L available iodine, 10 min contactEU 528/2012 PT3, USP monograph, 21 CFR Part 211Concentrate, ready-to-use solution, aerosol mist
    Surgical-site antisepsis and wound irrigation7.5% scrub; 10% solution; 0.1–0.2% irrigationISO 10993-1, EU GMP Annex 1, Ph. Eur. monographSurgical scrub, wound irrigation, navel dip, spray film
    Drinking-water sanitation for neonatal livestock5–20 mg/L available iodine in final waterEU 528/2012 PT5, WHO Guidelines, USP monographEffervescent tablet, sachet, premix granulate, jar
    Intrauterine tablets and capsules0.1–0.5% w/w available iodine in matrixPh. Eur. 01/2017:0662, VICH GL1, Ph. Eur. 2.9.40Intrauterine tablet, pessary, powder-filled capsule
    Aquaculture egg disinfection100 mg/L free iodine, 10 min contactWOAH Aquatic Code, EU 528/2012 PT3, discharge permitsConcentrate, ready-to-use egg dip, tank sanitiser

    Surgical-site preparation in equine and companion animal clinics uses a two-phase povidone-iodine protocol: a detergent-based scrub containing 7.5% w/w PVP-I, equivalent to 0.75% available iodine, followed by a solution or spray containing 10% PVP-I, equivalent to 1.0% available iodine. The scrub is dispensed from a closed-loop foaming system that mixes compressed air and the surfactant-stabilised iodophor at 3–5 bar; contact time is not less than 2 minutes before rinsing with sterile saline, because residual organic matter in hair follicles can deactivate free iodine. Wound irrigation is performed with a 0.1–0.2% available iodine dilution, freshly prepared by adding one part of 10% PVP-I to nine parts of sterile water for irrigation, yielding a final concentration that avoids fibroblast cytotoxicity while maintaining bactericidal activity against Staphylococcus aureus and Streptococcus equi. Manufacturing of the 10% solution is conducted by dissolution in purified water, pH adjustment to 4.5–5.5, and clarification through 0.45 μm polypropylene filtration; where sterile presentations are required, aseptic processing with 0.22 μm filtration is validated according to EU GMP Annex 1. The finished products include surgical scrub, teat scrub, wound irrigation solution, and sprayable film-forming solution for umbilical cord navel dipping in calves, all released under ISO 10993-1 biocompatibility for skin contact and pharmacopoeial appearance and colour stability specifications. Avoid mixing with hydrogen peroxide, enzymatic debriders, or reducing agents such as sodium thiosulfate because free iodine is rapidly consumed.

    Water-Soluble Effervescent Granulation for Neonatal Drinking-Water Sanitation

    Production of water-soluble povidone-iodine powders and effervescent granules for neonatal calf, goat, and piglet drinking-water systems begins with low-moisture dry blending of PVP-I API, malic or citric acid, sodium bicarbonate, sodium carbonate, and lactose or sorbitol as diluents. The granulation end-point is a moisture content below 0.5% Karl Fischer; fluid-bed granulation is conducted at inlet air 50–60 °C and product temperature below 35 °C to avoid premature acid-carbonate reaction and iodine loss. The final product is packed in cold-form aluminium foil with a 0.12 mm polyethylene inner layer after nitrogen flushing to residual oxygen below 2%; this packaging is validated by six-month accelerated stability at 40 °C/75% RH. At the use site, one effervescent tablet or sachet is dissolved in 100–500 L drinking water to achieve 5–20 mg/L available iodine; the target depends on incoming water organic load and is confirmed by colorimetric test kits calibrated for iodine. Effervescent tablet compression is performed on chromium-plated tooling under 25% RH or less, with compression force between 8 kN and 15 kN and tablet hardness between 40 N and 70 N; disintegration is evaluated at 20 °C in 500 mL water and must complete within 5 minutes. Compliance for the finished formulation is anchored to EU 528/2012 product-type 5 drinking water disinfectants, WHO Guidelines for Drinking-water Quality for residual disinfectant, and 21 CFR Part 210/211 where registered as a veterinary medicinal product; the API itself is tested to the USP povidone-iodine monograph, including loss on drying 8.0% and available iodine between 9.0% and 12.0% w/w. This water-sanitizing premix must not be confused with nutritional iodine premixes based on calcium iodate or potassium iodide. Terminal product classes include 5 g effervescent tablets, 20 g single-dose sachets, 1 kg jars, and bulk 25 kg drum granulate for stationary dosing systems in swine barns.

    Direct compression of povidone-iodine intrauterine tablets in bovine reproduction requires a dry granulation path because moisture-activated release of free iodine corrodes tooling and oxidises lubricants such as magnesium stearate. The PVP-I API is pre-screened through 40 mesh and blended with anhydrous dicalcium phosphate, microcrystalline cellulose, crospovidone, and sodium starch glycolate for 15–20 minutes in a V-blender at 70–80% fill volume; tableting is performed on a rotary press with 10–12 kN main compression force and 5–8 kp target tablet hardness. Moisture is controlled below 40% RH in the compression suite, and bulk hold time is less than 8 hours, because PVP-I is hygroscopic and free iodine activity increases in humid air. Blend uniformity is verified at 10 sampling points with relative standard deviation below 5.0%. Available iodine in the finished intrauterine unit is commonly adjusted to 0.1–0.5% w/w by varying the PVP-I assay input; release testing uses iodometric titration and disintegration testing in simulated uterine fluid at 38.5 °C. Compliance is maintained through Ph. Eur. 01/2017:0662 for povidone-iodine, VICH GL1 stability protocols, EU GMP Part 4 for veterinary medicinal products, and Ph. Eur. 2.9.40 uniformity of single-dose preparations. Photosensitivity is managed by packaging uncoated tablets in opaque aluminium or amber blister because a moisture-permeable film coating can initiate early iodine migration. Terminal dosage forms include intrauterine tablets, pessaries, and powder-filled capsules for large animal intrauterine application; no parenteral injection indication is recognised, and published data for injectable PVP-I formulations is limited because systemic iodine exposure presents toxicity risks outside narrow therapeutic thresholds.

    Aquaculture Egg Disinfection in Recirculating Hatchery Systems

    In salmonid and marine finfish hatcheries, povidone-iodine iodophors are applied to fertilised eggs to reduce surface pathogens including Aeromonas salmonicida and Flavobacterium psychrophilum without systemic exposure. The disinfection bath is prepared at 100 mg/L free iodine for 10 minutes, with water temperature matched to the incubation system within ±1 °C; the eggs are continuously stirred with plastic paddles or air stones during exposure, and the spent solution is discharged through activated carbon or sodium thiosulfate neutralisation before release. Use of PVP-I in this application is governed by WOAH Aquatic Animal Health Code provisions for disinfection of fish eggs, local veterinary biologic registration conditions, and EU 528/2012 product-type 3; residual iodine in hatchery effluent must not exceed 0.1 mg/L after neutralisation where permitted by discharge permits. The API batch used for aquaculture concentrates is released with a narrow available iodine range of 9.0–12.0%, a crystallisation-free clarity test at 5 °C, and endotoxin control below 0.5 IU/mL for immersion products. Buffer capacity is adjusted with citric acid to maintain pH between 5.0 and 6.0 during the contact period, because alkaline hatchery water shortens free iodine persistence. Equipment contacting the concentrated iodophor is selected from polypropylene, polyethylene, or titanium to avoid corrosion; UV exposure and freezing are prevented because both accelerate iodide/iodate imbalance and reduce available iodine. Terminal product types include 10% iodophor concentrate in 20 L jerrycans, 1% ready-to-use egg dip, and iodophor surface sanitiser for tank equipment.

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    Certification & Compliance
    More Introduction

    Povidone-Iodine, the nonproprietary name for the 1-ethenyl-2-pyrrolidinone homopolymer–iodine complex assigned CAS 25655-41-8, is supplied as a reddish-brown amorphous powder under the trade names Isodine® and Betadine®. The veterinary-grade active pharmaceutical ingredient is defined by the USP Povidone-Iodine monograph rather than by a separate model designation. The complex contains not less than 9.0% and not more than 12.0% available iodine on the dried basis. This iodine reservoir is bound to povidone, and the product releases free molecular iodine through an equilibrium process that maintains antimicrobial activity while reducing the high vapor pressure and local irritancy associated with elemental iodine solutions.

    The delivery mechanism differs from iodine tincture. In aqueous dilution, the complex acts as a depot: free molecular iodine is maintained at a low concentration, commonly reported in the order of 1–2 ppm for a 10% w/v povidone-iodine preparation at use dilution, while total available iodine remains much higher. This reduces vapor pressure, local irritation, and staining compared with alcoholic iodine solutions. The equilibrium depends on pH and dilution; above pH 8, molecular iodine is rapidly converted to iodide and iodate species, and microbicidal activity is depleted. The product is therefore formulated and diluted in acidic or neutral aqueous vehicles, not alkaline buffers.

    What Pharmacopoeial Limits and Analytical Markers Apply to This Veterinary-Grade API?

    The veterinary API is released against the USP Povidone-Iodine monograph with additional controls appropriate for the intended dosage form. Certificates of analysis typically report appearance, available iodine, loss on drying, residue on ignition, elemental impurities, and residual solvents. The following matrix summarizes the principal compliance points.

    AttributeAcceptance criterionReference standard/method
    Available iodine9.0%–12.0% on dried basisUSP Povidone-Iodine monograph, iodometric titration
    Loss on dryingNot more than 8.0%USP <731>
    Elemental impuritiesRoute-specific limits per risk assessmentICH Q3D; USP <232>/<233>
    Bacterial endotoxins, if injection-gradeLimit assigned per finished productUSP <85>
    Sterility, if sterile finished productMust meet testUSP <71>
    Container closureTight, light-resistantUSP monograph; USP <671> for moisture permeation

    Because the powder is hygroscopic and light-sensitive, packaging in double polyethylene bags inside a fiber drum with a barrier liner is standard. Each lot is released against the USP monograph and a veterinary-specific risk assessment for the intended route of administration.

    Dosage-Form Processing of Povidone-Iodine Complexes in Solid and Liquid Veterinary Products

    Tablet forms are manufactured by direct compression or dry granulation; wet granulation is possible only with controlled temperature and nonaqueous binders. Direct compression formulations frequently contain microcrystalline cellulose and lactose monohydrate; however, lactose is a reducing sugar and can react with available iodine over prolonged storage, causing measurable loss of available iodine. Preferred fillers include dibasic calcium phosphate dihydrate and calcium sulfate. Tablet hardness and disintegration must be validated in the environment of use, because povidone-iodine tablets intended for intrauterine application require slow disintegration and prolonged iodine release rather than rapid oral disintegration.

    Hard gelatin capsules are generally inferior to hypromellose capsules for povidone-iodine powders because gelatin contains amino acid residues that can be oxidized by available iodine, leading to shell cross-linking or discoloration. If gelatin capsules are used, storage at low relative humidity below 40% RH is necessary to limit moisture-mediated iodine migration into the shell. Hypromellose capsules are specified where moisture resistance and lower oxidative sensitivity are required.

    For dry powders and premixes, the API is milled and blended with inert diluents such as sodium sulfate or calcium carbonate. Dust control is critical because liberated iodine vapor is irritating; containment systems with HEPA filtration and 316L stainless steel contact surfaces are specified. Blend uniformity is verified according to USP <905> for solid oral dosage forms or by equivalent veterinary validation protocols. The API should be preblended with a portion of carrier before addition to a tumble blender or ribbon blender to avoid localized high iodine concentration at the blender discharge.

    Aqueous solutions are manufactured by dissolving the API in purified water with mixing at ambient temperature. The resulting solution is acidic and generally does not require pH adjustment for topical use. Process equipment constructed of 316L stainless steel, polypropylene, high-density polyethylene, or glass-lined carbon steel is specified. Copper, aluminum, mild steel, and natural rubber are incompatible because iodine oxidizes the metal surface and attacks unsaturated elastomers. Silicone or fluorocarbon elastomers are used for seals.

    When Aqueous Granulation of the API Exceeds the Iodine-Liberation Threshold

    Wet granulation of povidone-iodine requires strict control of temperature and moisture because water mobilizes the complex and heat shifts the equilibrium toward free iodine. In production-scale high-shear mixers, impeller tip speed and wet massing time must be limited; an increase in iodine odor at the granulator discharge indicates iodine loss. Fluid-bed drying is performed with inlet air temperature not exceeding 55°C and product temperature below 45°C; vacuum drying at 40–50°C is preferred for heat-sensitive formulations. Exhaust air is passed through activated carbon or sodium thiosulfate scrubbers to prevent iodine release into the production environment. Published data for this specific configuration is limited; therefore, process qualification should include assays for available iodine at the start, middle, and end of drying. In the absence of such data, dry granulation or direct compression is preferred over aqueous wet granulation.

    Injection and Liquid Solution Requirements

    Injectable dosage forms containing povidone-iodine are not common in veterinary medicine because available iodine is a potent oxidant and can cause local irritation and systemic thyroid effects if absorbed. If a veterinary injectable product is developed, the API must meet bacterial endotoxin limits per USP <85>, the finished product must pass sterility testing per USP <71>, and packaging must protect against light because available iodine degrades in clear glass. Aqueous solutions for topical use are more common: a 10% w/v solution provides 1% available iodine and is typically diluted 1:10 to 1:100 before application. Filtration through inert polymeric membranes is used; nylon membranes may be incompatible. The pH of aqueous dilutions is acidic, and alkaline buffers above pH 8 must be avoided because they convert free iodine to iodide and iodate.

    The primary difference from potassium iodide and calcium iodate is pharmacological role: those salts are used as nutritional iodine sources in feed premixes, whereas povidone-iodine is an antiseptic iodophor and is not interchangeable with nutritional iodine sources intended to correct iodine deficiency. Compared with iodine tincture, povidone-iodine has a lower free iodine concentration, lower vapor pressure, and reduced tissue irritation while retaining broad-spectrum activity. Compared with chlorhexidine digluconate, povidone-iodine has documented activity against enveloped and non-enveloped viruses in EN 14476 testing; chlorhexidine is generally less active against non-enveloped viruses. Unlike quaternary ammonium disinfectants, povidone-iodine is not inactivated by hard-water cations and can be formulated in non-demineralized water.

    Storage conditions follow the USP monograph: tight, light-resistant containers at controlled room temperature, with excursions permitted between 15°C and 30°C. Moisture ingress must be limited because humid conditions accelerate iodine redistribution and caking. Each container is double polyethylene-lined, and desiccant may be added when the API is intended for use in dry premix or powder processing. Incompatibilities include strong reducing agents, ammonia, ammonium salts, and alkaline materials, all of which consume available iodine and reduce the antimicrobial capacity of the finished veterinary product.

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