| HS Code | 287466 |
| Product Name | Povidone Iodine (PVPI) Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Synonyms | PVP-I; Povidone-iodine; Polyvinylpyrrolidone-iodine complex |
| Cas Number | 25655-41-8 |
| Atc Code | D08AG02; G01AX11; R02AA15; S01AX18 |
| Molecular Formula | (C6H9NO)n·xI2 |
| Molecular Weight | Variable; approximately 111.9 g/mol for vinylpyrrolidone monomer; complex molecular weight varies |
| Appearance | Brown to reddish-brown amorphous powder |
| Odor | Faint characteristic odor |
| Iodine Content | 9.0%–12.0% w/w available iodine |
| Ph | 1.5–5.0 for a 10% w/v aqueous solution |
| Solubility | Soluble in water, ethanol, and glycerin; practically insoluble in chloroform, ether, and acetone |
| Grade | Pharma Grade / API |
| Dosage Forms | Tablet, Capsule, Granule, Injection |
| Route Of Administration | Oral and Injectable |
| Assay | 9.0%–12.0% available iodine |
| Loss On Drying | ≤ 8.0% |
| Heavy Metals | ≤ 20 ppm |
| Storage Conditions | Store in a cool, dry place, protected from light, in tightly closed containers |
| Packaging | Fiber drum with double polyethylene bags; customized packaging available |
| Shelf Life | 24–36 months when stored appropriately |
| Pharmacopoeia Compliance | USP/NF, EP, BP, IP, JP as applicable |
| Primary Function | Antiseptic and disinfectant |
| Mechanism Of Action | Releases free iodine, which oxidizes microbial proteins and nucleic acids |
As an accredited Povidone Iodine (PVPI) Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
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Povidone-iodine (PVPI) pharma grade API with available iodine 9.0–12.0% is processed exclusively into topical antiseptic and surface-disinfection dosage forms. A parenteral finished-dose presentation is not approved; the injectable grade designation functions only in the manufacture of pre-injection skin antisepsis products, preoperative ophthalmic preparations, and related procedural disinfectants. Capsule formats are not established for human PVPI administration. The downstream applications below specify the operational boundaries for each manufacturing route.
| Application | PVPI input | Available iodine target | Critical processing boundary | Terminal product |
| Effervescent disinfectant tablet/granule | 5.0–25.0% w/w | 0.10–0.50% w/v after dissolution | <30% RH, moisture <0.2% w/w | Disinfectant tablets, sitz bath tablets, single-dose granules |
| Oropharyngeal gargle/mouthwash | 0.5–1.0% w/v | 0.05–0.10% w/v | pH 4.5–5.5 | Gargle, mouthwash, throat spray, oral rinse |
| Surgical scrub/preoperative skin prep | 7.5–10.0% w/v | 0.75–1.0% w/v | pH 4.0–6.0, viscosity 800–2000 mPa·s | Hand scrub, skin prep solution, swab sticks |
| Ophthalmic preoperative antisepsis | 5.0% w/v | 0.5% w/v | pH 4.0–5.0, aseptic filtration 0.22 µm | Ophthalmic dropper, irrigation solution |
| Wound/burn semi-solid | 3.0–10.0% w/w | 0.3–1.0% w/w | Addition at 38–42°C | Ointment, cream, powder spray, impregnated gauze |
| Vaginal antiseptic gel/douche | 5.0–10.0% w/w | 0.5–1.0% w/w | pH 4.0–5.5, incorporation at 25–35°C | Vaginal gel, douche, perineal rinse |
Effervescent disinfectant tablets and granules for healthcare surface and instrument application begin with direct-compression or roller-compaction blending of PVPI with an anhydrous acid-carbonate effervescent pair. Wet granulation is not used because water addition initiates iodine release; production-scale direct compression on a rotary tablet press with 20–30 kN compression force and chromium nitride-coated D2 tooling is preferred because PVPI granule fines below 75 µm segregate in hopper flow. Forced feeder speed is kept below 30 rpm to reduce density variation and iodine dusting. The addition ratio of PVPI in the core tablet is adjusted from 5.0% to 25.0% w/w to achieve 0.10–0.50% w/v available iodine after dissolution in 100–500 mL water; the effervescent pair, typically anhydrous citric acid and sodium bicarbonate, occupies 55–75% w/w and must remain below 0.2% w/w moisture content. Processing relative humidity is held below 30% RH because PVPI deliquescence accelerates iodine release and causes brown specking in the final tablet. Cold-form aluminum foil blister packaging with desiccant is used to reduce moisture ingress. Terminal product types are disinfectant tablets, instrument soak tablets, and single-dose sachet granules for footbath and sitz bath preparation. Compliance is assessed against Ph.Eur. 10.0 Povidone-Iodine monograph, USP Povidone-Iodine monograph, 21 CFR 211.84 raw material verification, and disinfection label claims require EN 13727 bactericidal and EN 13624 fungicidal activity at the recommended use dilution.
In mouthwash-grade solutions, PVPI is added at 1.0% w/v to deliver 0.10% w/v available iodine for gargles; lower-strength 0.5% w/v formulations are used for daily oral rinses. The mixing sequence adds PVPI into demineralized water at 20–30°C under propeller agitation at 100–200 rpm; high-shear dispersion is not used because air entrainment accelerates iodide formation. pH is adjusted with citric acid/sodium hydroxide to pH 4.5–5.5, since above pH 6.5 available iodine shifts to iodide/iodate and below pH 2.5 mucosal irritation and container corrosion increase. The solution is transferred through polypropylene or borosilicate glass-lined lines rather than 316L stainless steel, because pitting initiates at weld zones after repeated contact with acidic iodophor solution. Reducing agents such as sodium metabisulfite, ascorbic acid, and amine-based flavor systems are excluded because they consume free iodine and reduce assay below label claim. Terminal forms include oral gargles, mouthwashes, throat sprays, and pre-procedural oral rinses. Release testing includes USP <61> total aerobic microbial count, USP <62> specified organisms, iodine assay by sodium thiosulfate titration, and pH stability under ICH Q1A(R2) accelerated conditions at 40°C ± 2°C / 75% RH ± 5% RH. Sterile mouthwash is not terminal-sterilized; if a sterile oral rinse is ordered, the solution is aseptically filled after membrane filtration.
When high surfactant loads are present in surgical scrub production, the incoming nonionic surfactant peroxide value becomes the primary batch-to-batch variable. Formulations use PVPI at 7.5% w/v or 10.0% w/v, delivering 0.75–1.0% w/v available iodine in a surfactant-thickened base; nonionic poloxamer 188 is used at 2.0–5.0% w/v and amphoteric cocamidopropyl betaine at 1.0–3.0% w/v. Incoming nonionic surfactant batches are screened for peroxide value above 5 meq O₂/kg and aldehydes above 10 ppm, because these impurities reduce available iodine by redox consumption. Production batches are mixed under vacuum in a planetary mixer to reduce air entrapment, then filled into HDPE bottles with induction-sealed caps; high-shear rotor-stator homogenization is avoided after PVPI addition due to foam generation and iodine volatilization. Because surfactant-iodine complexation can reduce free iodine independently of total iodine content, release uses sodium thiosulfate available iodine titration rather than total iodine assay. Terminal products include surgical hand scrub, patient preoperative skin preparation, injection-site swab sticks, and preoperative paint applicators. In vivo efficacy for skin antisepsis is evaluated according to ASTM E1173; surgical hand disinfection claims use EN 12791; the OTC drug product framework is 21 CFR Part 333. Batch release includes available iodine titration, pH 4.0–6.0, and viscosity at 25°C in the range of 800–2000 mPa·s.
Ophthalmic preoperative antisepsis preparations are compounded as 5.0% w/v PVPI in Water for Injection, delivering 0.5% w/v available iodine, and are filled into single-use low-density polyethylene or amber glass droppers. The preparation is not autoclaved because terminal steam sterilization drives iodine loss; aseptic filtration through a 0.22 µm polyethersulfone membrane is used after dissolution, with filter integrity testing performed before and after filtration. pH is adjusted to 4.0–5.0 with sodium phosphate or citric acid buffers, and the solution is held in inert polypropylene or fluoropolymer-lined vessels because free iodine adsorbs onto some stainless-steel surfaces and reduces assay. Sterility is assessed by USP <71>, bacterial endotoxins by USP <85>, and particulate matter by USP <789>; the terminal product types are ocular surface preoperative antiseptic solution, intravitreal injection site preparation drops, and eyelid and cul-de-sac irrigation solutions. Clinical use concentration is not increased above 5.0% w/v for routine ocular surface antisepsis because higher available iodine concentrations cause corneal epithelial toxicity; published data for preservative-containing multidose PVP-I ophthalmic formulations is limited.
Above 50°C, PEG-based wound care bases induce measurable iodine sublimation; therefore PVPI is incorporated only after the melt has been cooled to 38–42°C. Wound and burn care semi-solid formulations use PVPI at 3.0–10.0% w/w in hydrophilic polyethylene glycol bases, producing 0.3–1.0% w/w available iodine; the base is melted at 55–65°C and cooled before PVPI addition. For dry powder spray configurations, talc or starch carriers are pre-dried to loss on drying below 1.0% w/w at 105°C before blending to prevent iodine reduction. The mixing vessel is specified with PTFE-lined scraped-wall agitator blades because 316L stainless steel contact at pH below 3.0 creates pitting and discoloration within 40 h of continuous exposure. Cream and ointment batches are deaerated under vacuum and filled into aluminum tubes with internal epoxy coating or HDPE tubes; terminal product types include antiseptic ointments, creams, dry powder sprays, and PVPI-impregnated gauze. Release specifications include USP <61> and USP <62> microbial limits, USP <51> antimicrobial effectiveness testing when the product is labeled as preserved, and iodine assay by USP Povidone-Iodine monograph titration. Reducing excipients such as glycerin-derived aldehydes, ascorbyl esters, and unsaturated fatty acid esters are excluded; their presence drops available iodine below 90.0% of label claim under accelerated stability at 40°C ± 2°C / 75% RH ± 5% RH.
To maintain available iodine and vaginal tolerance, bioadhesive gel systems are buffered at pH 4.0–5.5 before PVPI is incorporated at 25–35°C. Vaginal antiseptic gels and douche concentrates use PVPI at 5.0–10.0% w/w or 5.0% w/v for liquid douches; bioadhesive gels use hydroxyethyl cellulose or polyvinyl alcohol at 1.0–3.0% w/w, while carbomer is used only after partial neutralization to avoid excessive low pH that destabilizes the PVP-iodine complex. Production uses a planetary mixer with vacuum deaeration; hydrated polymer concentrate is cooled to 25–35°C before PVPI is added to prevent thermal release of iodine. Terminal product types are vaginal gels, douche solutions, and perineal preoperative antiseptic rinses. Compliance is verified by Ph.Eur. 10.0 monograph, ICH Q3D elemental impurity limits for cutaneous/vaginal routes, 21 CFR 211.165 release testing, and USP <61>/<62> microbial limits; sterility is not implied unless the product is aseptically filled and labeled sterile. Operational boundaries include exclusion of cationic polymers such as chitosan unless compatibility is proven by available iodine assay at 24 h and 72 h; published data for this specific cationic-combination configuration is limited.
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Povidone iodine (PVPI) pharma grade API is a water-soluble complex of iodine and povidone of controlled K-value, typically K29/32. The product is identified by CAS 25655-41-8 and is not a simple physical blend of iodine and PVP; the complex alters iodine vapour pressure, release kinetics, and staining behaviour. Pharmaceutical-grade material is released against monograph limits: available iodine 9.0%–12.0% w/w on the dried basis, iodide ≤6.0%, loss on drying ≤8.0%, pH 2.0–3.0 for a 1 in 20 aqueous solution, and residue on ignition ≤0.1%. Product nomenclature commonly encodes the PVP K-value and target available iodine; for tablet, capsule, and granule applications, the PVP K29/32 grade with available iodine in the 9.0%–12.0% range is specified. Injectable presentations use the same PVP backbone but require additional controls for sterility, bacterial endotoxins, and particulate matter. The grade requested must state the pharmacopoeial reference—USP-NF, Ph. Eur., BP, or JP—because impurity and residual solvent criteria differ among jurisdictions. For nonsterile oral solid presentations, the API release also includes microbial enumeration testing per USP <61> and absence of specified organisms per USP <62>.
Technical and disinfectant iodophor grades may display comparable available iodine but are not interchangeable with pharma-grade API. Technical material may have uncontrolled PVP molecular weight distribution, variable iodine content, and undefined levels of elemental impurities. Pharmaceutical PVPI is released under cGMP according to 21 CFR Part 211 and current monograph requirements. The PVP K-value is controlled because it influences aqueous solubility, complex stability, and dissolution from solid oral matrices. Residual solvent testing follows ICH Q3C, elemental impurities follow ICH Q3D, and the specific monograph test for heavy metals is retained where required. For solid oral dosage forms, no universal particle size is fixed by monograph; release data should include laser diffraction D10, D50, and D90 against supplier-specific limits because flow, segregation, and dissolution are affected. Table 1 summarises the core release profile.
| Parameter | Acceptance limit | Method principle |
|---|---|---|
| Available iodine | 9.0%–12.0% w/w dried basis | Iodometric titration |
| Iodide | ≤6.0% | Potentiometric silver nitrate titration |
| Loss on drying | ≤8.0% | Drying at 105 °C to constant weight |
| pH | 2.0–3.0 | 1 in 20 aqueous solution, potentiometric |
| Residue on ignition | ≤0.1% | Ignition at 600 °C |
| Heavy metals | ≤20 ppm | Ph. Eur. 2.4.8 or current compendial equivalent |
Formulation of PVPI into tablets, capsules, and granules uses conventional equipment, but the operational window is narrower than for typical water-soluble APIs. In high-shear granulation, PVPI is dissolved in purified water or a binder solution and sprayed onto a carrier such as microcrystalline cellulose or mannitol; jacketed bowl temperature is maintained at 20–30 °C to avoid thermal iodine loss. Aqueous granulation is feasible because the complex is freely water-soluble, but the drying step is critical. Fluid-bed dryers should operate with inlet air at 40–45 °C and product temperature not more than 40 °C; vacuum tray drying at shelf temperature 35–40 °C is preferred for heat-sensitive batches. Direct compression is often difficult because the amorphous powder is cohesive and prone to sticking; dry granulation by roller compaction or slugging improves flow and reduces segregation. Tablet compression is performed in humidity-controlled suites, generally maintained below 45% RH, because the API is hygroscopic and moisture uptake can cause picking, sticking, and available iodine loss. Lubricant selection is limited: magnesium stearate at 0.5%–1.0% w/w is commonly used, but extended mixing should be avoided because over-lubrication retards aqueous dissolution. Crospovidone and sodium starch glycolate are compatible disintegrants at 2%–5% w/w; basic fillers such as dibasic calcium phosphate dihydrate may alter the local pH and should be evaluated for iodine stability. Capsule and granule presentations may be packed in amber glass or opaque HDPE with desiccant because light and moisture degrade the complex.
PVPI intended for sterile injectable, irrigation, or cavity instillation presentations is a specialty grade that goes beyond oral API monographs. Systemic intravenous administration is not a routine use; published safety data for systemic injectable PVPI is limited, and injectable applications are generally confined to local irrigation or intraoperative use under clinical supervision. A sterile PVPI API must be processed by aseptic crystallisation, gamma irradiation, or sterile filtration after dissolution, because terminal steam sterilisation may drive iodine loss and pH drift. Sterility is verified by USP <71> or Ph. Eur. 2.6.1. Bacterial endotoxin testing follows USP <85> or Ph. Eur. 2.6.14; the limit must be derived from the maximum intended dose, and values such as 0.5 EU/mg may be requested for high-risk parenteral presentations. Subvisible particulate matter is controlled in the final sterilised solution according to USP <788> or USP <787> where appropriate, and container closure integrity is validated under USP <1207>. The API solution must be filtered through a 0.22 μm polyethersulfone or polytetrafluoroethylene membrane; prolonged contact with uncoated stainless steel should be minimised because halogen species can accelerate corrosion under low pH and warm conditions. Table 2 compares oral and injectable release requirements.
| Control parameter | Oral solid/mucosal API | Injectable/sterile API |
|---|---|---|
| Available iodine | 9.0%–12.0% w/w dried basis | 9.0%–12.0% w/w dried basis |
| Sterility | Not required | USP <71> sterile |
| Bacterial endotoxins | Not routinely specified | USP <85>, dose-derived limit |
| Particulate matter | Not required | USP <788>/<787> |
| Elemental impurities | ICH Q3D oral PDE | ICH Q3D parenteral PDE |
| Packaging | Amber glass or opaque HDPE with desiccant | Sterile Type I glass or validated polymer closure |
In oral liquid, gargle, and mucositis formulations, PVPI is dissolved in purified water to produce 0.5%–1.0% w/v available iodine solutions, with buffering to pH 4.0–6.0 using citric acid/disodium phosphate to reduce mucosal irritation. The concentrated API solution is acidic; direct neutralisation should be performed slowly with cooling because exothermic neutralisation and high local alkalinity can destabilise the iodine–PVP complex. Compared with elemental iodine, PVPI has lower vapour pressure, reduced odour, and less staining, but it remains an oxidising agent and must be separated from reducing excipients. Ascorbic acid, sodium metabisulfite, sodium thiosulfate, and other reducing agents consume available iodine and should be excluded. Ammonia and strong alkalis shift the equilibrium toward inactive iodide and should be avoided. The product is photolabile; aqueous and solid preparations should be stored in amber or opaque packaging at controlled room temperature, typically 15–30 °C, protected from light. The main difference from non-complexed iodine is not microbiological spectrum but handling and release: the PVP matrix slows iodine liberation, which reduces acute tissue irritation and improves compatibility with polymeric film-forming excipients used in oral films and sprays.
The principal process failure mode is available iodine loss, not loss of chemical identity. In a production wet-granulation train—such as a top-spray fluid-bed granulator or a jacketed high-shear mixer—product temperature excursions above 40 °C can produce measurable iodine loss within 30–60 min. Published stability data for povidone iodine formulations indicate accelerated iodine loss under combined heat and moisture; therefore, drying endpoints should be defined by moisture content, target 2%–6% for a finished granule, rather than fixed drying time. If a formulation contains a hygroscopic disintegrant, residual moisture after drying may be non-uniform; granules should be equilibrated and tested at multiple points before lubrication. A drop in available iodine of more than 0.5% absolute from API to finished granules generally indicates incompatibility or overexposure, and the unit operation must be re-evaluated. Compatibility screening at 40 °C/75% RH for 14–28 days is used to detect reducing sugars, amines, and basic fillers before scale-up. If iodine loss exceeds 5% of label claim, the excipient system is unsuitable without reformulation. For capsule filling, granules are sieved to a target D50 of 100–300 μm to ensure consistent fill weight on dosator and tamping-pin machines; finer material may agglomerate in humid conditions and cause sticking. The process area should maintain 35–45% RH for granule handling and compression, and operators must avoid metal tools that can initiate localised oxidation when wetted.
PVPI pharma grade differs from industrial iodophors and nonylphenoxypolyethoxyethanol-iodine complexes because povidone is a compendial polymer with defined K-value and established safety data; industrial iodophors may contain surfactants and are unsuitable for oral or injectable APIs. Release documentation should include batch-specific certificates for available iodine, iodide, loss on drying, heavy metals or elemental impurities, residual solvents, and microbial limits. For injectable or irrigation grades, the dossier should demonstrate sterility, endotoxin, particulate matter, and container closure data under current Good Manufacturing Practice. The product is incompatible with strong alkalis, ammonia, reducing agents, and prolonged contact with certain uncoated metals; these boundaries define the formulation space and must be addressed during scale-up.
