Povidone (PVP K30) CAS 9003-39-8

What is Povidone (PVP K30)?

Povidone is poly(1-vinyl-2-pyrrolidone), (C₆H₉NO)n — a synthetic water-soluble polymer whose usefulness comes from an unusual combination: it dissolves in water and in a wide range of organic solvents, it forms films, it binds powders, and it holds poorly soluble drugs in solution and in the amorphous state.

It is supplied by K value, a viscosity-derived number that stands in for molecular weight. K30 sits in the middle of the range at a K value of 27 to 33, corresponding to a molecular weight around 40,000 to 50,000, and it is the grade that dominates tablet binding because it gives good binding power without making the granulating solution unmanageably viscous.

The material is a white to creamy-white hygroscopic powder with no meaningful taste or odour. Hygroscopicity is its defining handling property: an open bag in a humid plant will gain weight measurably, and the water it takes up changes granulation behaviour before it changes anything on a certificate.

Commercially povidone is a high-volume excipient with two quite different demand profiles. The bulk of it goes into tablets as a granulation binder at a few percent. The faster-growing part goes into solid dispersions and amorphous formulations, where it is doing something much harder — keeping a poorly soluble drug from crystallising, sometimes for years.

Why povidone specifically

• Soluble in water and in organics. Few binders dissolve in both, which is what lets the same material be used for aqueous and for alcoholic granulation.
• Strong binding at low levels. Two to five percent is usually enough, so it adds binding without displacing much active or filler.
• Holds drugs amorphous. In solid dispersions it inhibits recrystallisation of a poorly soluble drug, which is the whole basis of several modern bioavailability-enhancement strategies.
• The K value gives you a dial. Lower K for easier processing and faster dissolution, higher K for stronger binding and more viscous films — one chemistry, a usable range of behaviour.

How Povidone is Manufactured

Povidone is made by polymerising N-vinylpyrrolidone in water. The monomer route is long, and the residual monomer limit is the specification that most reflects how well the whole chain ran.

• Monomer manufacture. Acetylene and formaldehyde give butynediol, hydrogenated to butanediol and cyclised to gamma-butyrolactone. Reaction with ammonia gives 2-pyrrolidone, which is vinylated with acetylene to N-vinylpyrrolidone.
• Polymerisation. The monomer is polymerised in aqueous solution with a free-radical initiator, typically hydrogen peroxide. Initiator level and conditions set the chain length and therefore the K value.
• K value control. This is the key process parameter and the basis of the product grades. It is measured as a solution viscosity, not as an absolute molecular weight.
• Spray drying. The polymer solution is spray dried to a free-flowing powder. Drying conditions affect particle size, bulk density and residual moisture.
• Residual control. Residual vinylpyrrolidone monomer, 2-pyrrolidone, peroxides and aldehydes are all limited by the monographs and all reflect the care taken in polymerisation and drying.

Typical Commercial Specification

Figures below are representative of pharmacopoeial K30. Other K values and low-peroxide grades are available — send us the specification or the monograph you work to.

Physical & Chemical Properties

Behaviour in the formulation

Povidone is doing physical work rather than chemical work, but it is not inert. Five behaviours matter:

• Binding. Dissolved in the granulating fluid, it forms bridges between particles that survive drying, giving granules that compress well.
• Solubilisation. It increases apparent solubility of poorly soluble drugs by complexation and by wetting.
• Crystallisation inhibition. In a solid dispersion it raises the glass transition temperature and physically restricts molecular mobility, keeping the drug amorphous.
• Film formation. Clear hard films from aqueous or alcoholic solution, used in coating and in topical and personal care products.
• Peroxide-mediated oxidation. Residual peroxides from manufacture degrade susceptible actives over time — the most important chemical interaction and the least often anticipated.

Povidone K Values and the Alternative Binders

Within povidone the choice is K value; between binders the choice is about solubility, viscosity and how the granule behaves after drying.

Stated plainly: K value trades processability against binding power. K30 is the default because it sits where the granulating solution is still pumpable and the binding is still strong. Go lower when viscosity is limiting your process, higher when you need film strength or long-term amorphous stabilisation — and consider copovidone when the binding has to happen dry.

Industries We Supply Povidone To

The same white powder goes to a tablet plant, a bioavailability-enhancement project and a personal care line. What changes between them is the K value, the peroxide limit and the documentation each sector expects.

Where Povidone is Used

Povidone is bought for binding, for solubility and for stabilising the amorphous state. These are the end uses our customers buy it for.

As a wet granulation binder

Dissolved in water or alcohol and sprayed onto a powder bed, povidone forms bridges that hold the granule together through drying and compression. Two to five percent is usually enough, which keeps the formulation efficient. The practical decisions are solvent choice, binder concentration in the fluid and whether to add the povidone in solution or dry — all of which change granule hardness and the dissolution profile that follows from it.

In solid dispersions and bioavailability enhancement

This is where povidone does its most demanding work. Dissolving a poorly soluble drug with the polymer and removing the solvent, or extruding the two together, gives a molecular dispersion in which the drug is amorphous and therefore far more soluble than its crystal form. The polymer's job is to stop it crystallising again, over the product's whole shelf life, which it does by raising the glass transition temperature and restricting mobility. The peroxide and moisture specifications matter enormously here, because both undermine that stability.

In povidone-iodine and personal care

The complex povidone forms with iodine is the basis of povidone-iodine antiseptics — it holds the iodine, releases it slowly and makes it far less irritant than free iodine. In personal care the same film-forming property gives hair styling products their hold and skincare products their substantivity. These markets usually specify colour and odour more tightly than pharmaceutical users.

Quality Control & Testing

Every lot is released against a batch-specific Certificate of Analysis written against the monograph you nominate, with the residual figures that drive stability reported alongside the identity tests.

• K value — determined from solution viscosity. The defining grade parameter and the first thing to check against your qualification lot.
• Water content — Karl Fischer. The material is strongly hygroscopic, so this figure moves with storage as well as with manufacture.
• Peroxides — the stability-critical figure for oxidation-sensitive actives, and the one most often omitted from a basic certificate.
• Aldehydes — relevant wherever the active carries a primary amine that could condense with them.
• Residual vinylpyrrolidone monomer — a toxicological limit, controlled to 10 ppm.
• Nitrogen content and pH — compendial identity and purity confirmation.
• Microbial limits — total aerobic count, yeasts and moulds, and absence of specified organisms per the monograph.

Common Process Problems & Likely Causes

When povidone causes trouble in a formulation, the cause is usually one of a short list of things — and the most serious ones appear in stability rather than in processing. This table is the shortcut our technical desk works through before anyone opens a complaint file.

Packaging, Storage & Shipping

• Standard packing. 20 or 25 kg net in fibre drums or multi-ply bags with polyethylene inner liners, palletised and shrink-wrapped.
• Hygroscopicity. This is the governing handling property. Keep liners tied and containers closed; an open bag in a humid plant gains weight measurably within hours.
• Storage. Cool, dry and well-ventilated, away from direct sunlight and from oxidising agents. Low humidity storage materially extends usable life.
• Moisture barrier. Where the material feeds a solid dispersion, consider dedicated low-humidity storage — moisture plasticises the polymer and undermines the amorphous stability you are paying for.
• Peroxide growth. Peroxide content can rise slowly in storage, particularly at elevated temperature. For oxidation-sensitive actives, use fresh stock and re-test rather than relying on the original certificate.
• Dust control. A fine powder; charge under local exhaust ventilation and avoid free-fall transfers.
• Shelf life. Typically 36 months in unopened original packing under those conditions. Re-test water content and peroxides rather than assume.
• Transport classification. Not classified as a dangerous good for transport.

Hazards & Safe Handling

Povidone is a well-tolerated excipient with a long history of pharmaceutical use and no significant toxicity by normal routes of exposure. The handling considerations are physical rather than toxicological.

• Dust explosion risk. Like any fine organic powder, airborne povidone in sufficient concentration presents a dust explosion hazard. Earth and bond transfer equipment and control ignition sources.
• Nuisance dust. Not toxic, but airborne dust irritates the respiratory tract mechanically. Local exhaust ventilation at charging and dispensing points.
• Eye contact. Mechanical irritation only. Safety glasses during dispensing and transfer.
• PPE. Dust mask where dust is generated, safety glasses and normal plant workwear. No special chemical protection is required.
• Slip hazard. Spilled povidone becomes slippery when wet, since it dissolves readily. Clean spills dry before washing the area.
• Incompatibilities. Strong oxidising agents. In formulation terms, the interactions that matter are with oxidation-sensitive and amine-containing actives, through residual peroxides and aldehydes.
• Spill response. Sweep or vacuum avoiding dust clouds. No special decontamination needed.
• Environment. Not hazardous to the aquatic environment. Dispose as ordinary industrial waste in line with local regulations.

Regulatory & Compliance Notes

Povidone is a compendial excipient with monographs in all the major pharmacopoeias and a long record of regulatory acceptance. Because obligations differ by territory and use, the notes below are orientation rather than legal advice — confirm your own position with your regulatory adviser.

• Pharmacopoeial status. Monographs in IP, BP, Ph. Eur. and USP. We supply against the monograph you nominate, with a compliance statement on the COA.
• K value on the filing. Marketing authorisations generally specify the K value, so changing grade is a variation rather than a purchasing decision. Confirm which grade is filed before switching.
• Residual monomer limit. Vinylpyrrolidone is controlled to 10 ppm on toxicological grounds and is a standard compendial test.
• Food and supplement use. Permitted in food supplement and food applications in the major regulatory systems, within the conditions that apply in your market.
• Excipient GMP expectations. Supply chains for compendial excipients increasingly expect documented GMP and supplier qualification. Tell us what your quality agreement requires.
• Supporting statements. BSE/TSE, allergen and GMO statements supplied as standard; it is a wholly synthetic polymer with no animal-derived input.

We Supply Povidone Worldwide

Chelora Chemicals is a supplier and export partner, not a single-plant trader. We ship Povidone (PVP K30) from India to customers across Asia, Europe, the Middle East, Africa, and North and South America, handling the export documentation, pharmacopoeial documentation and freight so the material arrives ready to use.

• Incoterms. EXW, FOB, CIF, CFR and DAP quoted to suit your purchasing terms and freight arrangements.
• Ports. Regular shipments through Nhava Sheva (JNPT) and Mundra, with other Indian ports arranged where it suits the routing.
• Documentation. Commercial invoice, packing list, certificate of origin, COA, SDS and the monograph compliance and supporting statements issued as a complete set.
• Flexible volumes. A single bag for laboratory qualification, through LCL consolidations, up to repeat full container loads on a supply contract.
• Supply continuity. Because we are independent of any one producer, a plant turnaround or a shipping disruption at one source does not have to become your stock-out.

Buying Povidone from Chelora

We are an independent sourcing and supply partner. For povidone that means settling two things at enquiry: the K value, because it is on your filing and not interchangeable, and whether your active is oxidation- or amine-sensitive — because that decides whether the standard peroxide and aldehyde limits are good enough.

• Documentation on every lot. Batch-specific COA written against the nominated monograph, with K value, water, peroxides and aldehydes reported, plus SDS, TDS and supporting statements.
• Samples before commitment. Trial quantities for formulation qualification ahead of a commercial order.
• Quantities. From a single 25 kg bag through to full container loads on contract supply.
• Grade range. K12, K17, K25, K30 and K90, with low-peroxide grades where your stability data requires them.
• Export experience. Packing, labelling and export documentation handled for sea and air freight.
• Related excipients. MCC, lactose monohydrate, HPMC and magnesium stearate from one supplier, which keeps a whole granulation formula on a single order.

How ordering works

• Send the enquiry. Product, grade or pharmacopoeia standard, quantity, destination port and the Incoterm you buy on. If you have a spec sheet, attach it — it saves a round trip.
• We quote. Price, lead time, packing and a sample COA, normally within one working day.
• Sample and qualify. For first orders or critical applications, we send a trial quantity so your lab can sign off before you commit.
• Confirm the order. Proforma invoice issued; payment terms agreed against the volume and the relationship.
• Production and QC. Material allocated and released against a batch-specific COA, with a pre-shipment sample where the application calls for it.
• Ship and document. Packed, labelled and loaded with the full export document set, and tracked through to arrival.

Related Pharmaceutical Excipients & Intermediates

Buyers of povidone usually source several of these alongside it — most granulation formulations use four or five of them together. Consolidating them on one order cuts freight cost and gives you a single point of contact for documentation.