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POLYVINYLPYRROLIDONE K 30

Polyvinylpyrrolidone K 30, a medium-molecular-weight, water-soluble synthetic polymer obtained by polymerization of the N-vinylpyrrolidone monomer. This grade, with a K-value of 30, is supplied as a white to slightly yellowish, hygroscopic, free-flowing powder; it dissolves in water, ethanol, isopropanol and many polar solvents. Its average molecular weight is reported as roughly 38,000 to 58,000, depending on the measurement method and the manufacturer; it gives low-viscosity solutions.

Povidone K 30, one of the most widely used binders in tablet granulation. It increases the dissolution rate of poorly soluble active ingredients by forming solid dispersions, and in hair and oral care products it provides a transparent film and a stain-binding effect. Because of its short-chain structure its solution stays fluid, which makes it an easy-to-handle component in water-based systems.

PVP K 30, a dispersant, binder and colloid protector in many branches of industry, from glue sticks to water-based inks, from membrane production to battery electrodes, and from detergent formulations to nanomaterial synthesis. In selection, the grade, moisture, residual monomer and peroxide level and the manufacturer’s documents should be evaluated together. This product can be supplied from ATAMAN KİMYA; for technical information and requests, contacting ATAMAN KİMYA is recommended.


WHAT IS POLYVINYLPYRROLIDONE K 30?

Polyvinylpyrrolidone K 30 is a linear, non-ionic polymer produced by free-radical polymerization of the N-vinylpyrrolidone (NVP) monomer. It is the medium-chain member of the family; it appears as povidone in pharmacopoeias and food legislation, and in trade it is known under grade names such as K 30 or K 29/32.

Each repeat unit of the chain carries a five-membered lactam ring, that is, a pyrrolidone group, attached to the main chain. The carbonyl oxygen in the ring is a strong hydrogen-bond acceptor, while the methylene groups give the chain a limited hydrophobic character. This dual character allows the substance to dissolve both in water and in many organic solvents.

The 30 in the name is the K-value, calculated from the viscosity of the polymer in dilute solution using the Fikentscher equation. For grades with a K-value above 15, the European and American pharmacopoeias accept 90–108 percent of the nominal value, which corresponds to a range of 27.0 to 32.4 for K 30. The manufacturers’ own ranges also vary between 27.0–32.0 and 29.0–32.0.

K 30 lies between the low grades such as K 12 and the high grades such as K 90. Its solution remains low in viscosity, its binding power is sufficient for most tablet and cosmetic applications, and it dissolves quickly. This balance makes it one of the most preferred grades in pharmaceuticals and personal care.

Manufacturer documents give the molecular weight with different figures. BASF reports a weight-average value of 38,000–56,000 for Kollidon 30; for Ashland Plasdone K-29/32 it gives about 58,000, and for BASF Luviskol K 30 about 45,000. The difference mostly comes from the measurement method and from the limits of the grade.

The substance is a white to slightly yellowish powder, odorless or with a very faint odor. It readily takes up water from the environment; it dissolves in water, ethanol, methanol and isopropanol and does not dissolve in ether and hydrocarbons. K 30 mostly consists of spherical particles obtained by spray drying; some grades are also sold as a solution containing about 30 percent solids.

It should not be confused with cross-linked, water-insoluble polyvinylpolypyrrolidone (PVPP, crospovidone). This is a separate substance; it is used as a tablet disintegrant and as a beer and wine clarifier, is known by the code E 1202, and does not replace soluble povidone.

Its main functions are binding, film forming, solubilizing, retarding crystallization, dispersing and colloid protection. In products such as tablets, hair styling products, oral care products, glue sticks, inks, membranes and electrode slurries, one or several of these functions are used together.

Production is based on polymerizing N-vinylpyrrolidone with a free-radical initiator in an aqueous or 2-propanol medium. After the reaction the solution is dried, residual monomer and by-products are reduced to a low level, and the product is offered in different particle sizes.

The name K 30 alone is not enough for selection. The grade (pharmaceutical, food, cosmetic or technical), moisture, residual monomer, peroxide and impurity limits and the manufacturer’s documents should be evaluated together.


COMMON PRODUCT AND CHEMICAL NAMES OF POLYVINYLPYRROLIDONE K 30:

Polyvinylpyrrolidone K 30
Polyvinyl pyrrolidone K 30
Povidone K 30
Povidone K30
Povidone K-30
Povidone K 29/32
Povidone K 30 (pharmacopoeial name)
Polividone K 30
Polyvidone K 30
PVP K 30
PVP K30
PVP K-30
PVP K 29/32
PVP USP K 30
Povidone USP
Poly(N-vinylpyrrolidone)
Poly(1-vinylpyrrolidin-2-one)
Poly(1-ethenylpyrrolidin-2-one)
Poly[1-(2-oxo-1-pyrrolidinyl)ethylene]
N-vinylpyrrolidone homopolymer
1-ethenylpyrrolidin-2-one homopolymer
2-Pyrrolidinone, 1-ethenyl-, homopolymer
Vinylpyrrolidone polymer
E 1201
Kollidon 30
Plasdone K-29/32
Luviskol K 30
Luvitec K 30
Agrimer 30
Vivapharm PVP K30

Most of these names describe the same product in different spellings. Povidone is the general name used in pharmacopoeial and regulatory language; polyvidone is an older and less used spelling; PVP is the international abbreviation of polyvinylpyrrolidone.

The names K 30 and K 29/32 describe the same grade. The 29/32 in the name of the Ashland product shows the K-value range accepted by the manufacturer; BASF offers the same grade under application-specific names such as Kollidon 30, Luviskol K 30 and Luvitec K 30.

Kollidon, Luviskol and Luvitec are trade names of BASF, while Plasdone and Agrimer are those of Ashland; Vivapharm is the povidone series of JRS Pharma. In pharmaceuticals mainly Kollidon, Plasdone and Vivapharm are offered, in cosmetics Luviskol, and in technical applications Luvitec and Agrimer.

Similar names may cause confusion. Polyvinylpolypyrrolidone (PVPP, crospovidone, CAS No 25249-54-1) has a cross-linked, insoluble structure; products sold under names such as Polyclar and Divergan belong to this group. N-vinylpyrrolidone (CAS No 88-12-0) is the monomer of the polymer and is a separate substance.

Copovidone (a copolymer of vinylpyrrolidone and vinyl acetate, CAS No 25086-89-9) is also a different polymer; it is sold under names such as Kollidon VA 64 and Luviskol VA. Povidone-iodine (CAS No 25655-41-8) is a complex of the polymer with iodine and is used as an antiseptic.

When a request or order is written, the product name, the CAS number and the K-value should be stated together. Because products of very different molecular weights are sold under the same CAS number, the CAS number alone does not define the K 30 grade.


CAS NO, EC / EINECS NO AND CHEMICAL IDENTIFICATION OF POLYVINYLPYRROLIDONE K 30

Product name: Polyvinylpyrrolidone K 30

Common abbreviation: PVP K 30; pharmacopoeial name povidone K 30

Chemical name: Poly(1-vinylpyrrolidin-2-one); 1-ethenylpyrrolidin-2-one homopolymer

INCI name: PVP

Food additive number: E 1201 (INS 1201)

CAS No: 9003-39-8

EC / EINECS No: Because it is a polymer there is no single identifying number; some documents give 201-800-4, the number of the monomer N-vinylpyrrolidone

Molecular formula: (C₆H₉NO)ₙ

Molecular weight: 111.14 g/mol for the repeat unit; in the K 30 grade the average molecular weight is roughly 38,000–58,000, depending on the measurement method and the manufacturer

K-value: Nominal 30; 27.0–32.4 in the pharmacopoeias

Chemical class: Synthetic, non-ionic, water-soluble polymer; N-vinyllactam homopolymer

Main functions: Binder, film former, solubilizer, dispersant, colloid protector, crystallization retarder, tackifier, stabilizer

Polymers are excluded from the registration obligation under the European REACH regulation; the monomer N-vinylpyrrolidone, on the other hand, is registered, and residual monomer limits are set separately in pharmacopoeias and food legislation. The current status should be confirmed with the supplier.

The CAS number is necessary to match the product with the correct substance; however, it does not indicate the K 30 grade on its own. Pharmaceutical, food, cosmetic and technical grades are sold under the same number and cannot automatically be used in place of one another. For example, one manufacturer’s cosmetic K 30 powder states explicitly that it is not intended for use in pharmaceutical preparations.

The existence of an INCI name does not mean that the product can automatically be used in cosmetics, nor does the existence of an E 1201 number mean that every food use complies with the legislation. For each application the grade, the level of documentation and the legal limits should be evaluated separately.


CHEMICAL STRUCTURE AND MOLECULAR PROPERTIES OF POLYVINYLPYRROLIDONE K 30

The main chain is a saturated carbon–carbon backbone formed by the polymerization of the vinyl group. An N-pyrrolidone ring is attached to every second carbon atom; the nitrogen in the ring, together with the carbonyl carbon, forms a tertiary amide, that is, a lactam structure.

For K 30 the chain consists of roughly 350 to 500 units, with a repeat unit of 111.14 g/mol. This figure is an approximation calculated from the weight-average molecular weight range of 38,000–56,000; the actual distribution is broad and consists of a mixture of short and long chains.

Because there is no hydrogen bonded to the nitrogen atom, the molecule is not a hydrogen-bond donor; it acts only as a hydrogen-bond acceptor through the carbonyl oxygen. In this way it forms strong bonds with hydroxyl-containing substances such as phenols, carboxylic acids and alcohols.

The high dipole moment of the amide group gives the chain a marked polarity. The backbone and the ring methylenes, on the other hand, form apolar regions. This balanced structure explains why the polymer dissolves in water, alcohols, chlorinated solvents and some amines and acids, and does not dissolve in ether and saturated hydrocarbons.

The polymer is non-ionic; it carries no charge in solution. For this reason it can be used together with surfactants, salts, most dyes and acids. The pH of solutions depends less on the polymer itself than on production residues and on the measurement concentration.

The chains are arranged irregularly and the substance is amorphous; it does not show a distinct crystalline melting point. Instead it has a glass transition temperature; for K 30, sources report values between roughly 149 and 171 °C, and moisture lowers this temperature markedly.

The binding of water by the carbonyl groups is the reason the substance is hygroscopic. At ambient humidity the polymer absorbs water, is plasticized, and its glass transition temperature falls. A BASF document states that at about 80 percent relative humidity (25 °C) the product takes up so much water that it passes into solution.

The polymerization product may contain small amounts of by-products such as 2-pyrrolidone, formic acid and aldehyde, as well as residual N-vinylpyrrolidone. Limits for these components are defined in the pharmacopoeias; in some K 30 SDSs the 2-pyrrolidone content is also mentioned as about 2 percent.

The tertiary carbon–hydrogen bonds next to the nitrogen are sensitive to oxygen. During storage, hydroperoxides may form at these sites; for this reason a peroxide limit has been set, and low-peroxide grades and oxygen-barrier packaging have been developed.

Under the action of a strong acid or base at high temperature, the amide bond may be hydrolyzed and the ring opened. Strong oxidizers shorten the chain or form by-products; therefore compatibility with oxidizing substances is important in use.

The calculated solubility parameter is in the range of about 22–23 MPa½. Good miscibility is expected with active ingredients and solvents whose parameters are close to this value; this property is exploited in amorphous solid dispersions.


PHYSICAL AND CHEMICAL PROPERTIES OF POLYVINYLPYRROLIDONE K 30

General technical specifications:

The values below were compiled from the data sheets, SDSs and pharmacopoeial monographs of different manufacturers. They vary with the measurement method, the manufacturer and the grade; the list provides general information and does not replace manufacturer-specific TDS and SDS documents.

Physical appearance: White to slightly yellowish, odorless or very faintly odorous, hygroscopic and free-flowing powder; mostly spherical particles

Chemical character: Non-ionic, amorphous, linear vinylpyrrolidone polymer; soluble in water and polar solvents

Molecular formula: (C₆H₉NO)ₙ

Molecular weight: 111.14 g/mol for the repeat unit; average molecular weight 38,000–56,000 at BASF, about 58,000 at Ashland, about 45,000 for Luviskol K 30; 40,000 on some catalogue labels

CAS No: 9003-39-8

EC / EINECS No: There is no single number for the polymer; some documents show 201-800-4, the number of the monomer

K-value: Nominal 30. Pharmacopoeial range 27.0–32.4; 27.0–32.0 is given for Kollidon 30, 29.0–32.0 for Plasdone K-29/32 and 27.0–33.0 for Luviskol K 30 (1 percent aqueous solution, 25 °C)

Purity (assay): Defined by the nitrogen content on the dry basis; the pharmacopoeial limit is 11.5–12.8 percent. For cosmetic-grade K 30 powder the solids content is given as 95–100 percent

Density: For the true density, one SDS reports about 1.2 g/cm³ at 20 °C and another a range of 1.23–1.29; this value is the density of the polymer itself, not the bulk state of the powder

Bulk density: 0.45–0.55 g/mL for Kollidon 30; 400–600 kg/m³ in an Ashland SDS, and a typical 0.36 g/cm³ (tapped 0.47 g/cm³) for Plasdone K-29/32. These values are characteristic and are not specifications

Viscosity: Low. In a 5 percent aqueous solution at 25 °C about 2.5 cP is reported for Plasdone K-29/32 and about 3 cP for Agrimer 30. Below concentrations of 10 percent the effect on consistency is small; solutions can remain fluid up to 60 percent

Solubility in water: Very good; far above 10 g/L for Kollidon 30, and 100 mg/mL (20 °C) is stated in one catalogue entry. It also dissolves in ethanol, isopropanol, methanol, propylene glycol, glycerol, PEG 300/400 and chloroform; it does not dissolve in cyclohexane, ether, ethyl acetate, toluene and liquid paraffin

pH (aqueous solution): Depends on the concentration and the measurement method. For a 5 percent solution the European Pharmacopoeia gives 3.0–5.0; for Luviskol K 30, 3.0–7.0 is reported in a 10 percent solution, and for Agrimer 30, 5.8–6.8 at 5 percent

Glass transition temperature: 171 °C for Kollidon 30 (DSC, second heating), about 163 °C for Agrimer 30; about 149 °C is given in some studies. This value falls markedly as moisture increases

Decomposition: Softens gradually on heating; decomposition above about 200 °C is reported. Combustion products are carbon oxides and nitrogen oxides; one SDS gives an auto-ignition temperature above 400 °C and a lower explosion limit of 15 g/m³

Moisture: At most 5 percent in the pharmacopoeias; because the product is hygroscopic, moisture increases in open packaging. An Agrimer document states that the equilibrium moisture is about one third of the relative humidity

Heavy metals (Pb, Cu, etc.): Heavy metals at most 10 ppm in the pharmacopoeias and lead at most 10 ppm in the USP; EU food additive specifications give at most 2 mg/kg for lead

Residual monomer and impurities: In the Ph.Eur., N-vinylpyrrolidone at most 10 ppm, hydrazine at most 1 ppm, peroxide at most 400 ppm as hydrogen peroxide, aldehyde at most 500 ppm, 2-pyrrolidone at most 3 percent, formic acid at most 0.5 percent and sulfated ash at most 0.1 percent. For cosmetic grade, at most 100 ppm is given for residual monomer

Particle size: For Kollidon 30, up to 40 percent below 50 µm and at most 5 percent above 250 µm by sieving; d(0.5) of 43–88 µm by laser diffraction; an average of about 80 µm for Plasdone K-29/32. Flow and particle size values are characteristic, not specifications

Reactivity: Stable under normal conditions. Incompatible with strong oxidizers and strong bases; prone to peroxide formation and moisture uptake during storage; as a fine powder it may form combustible dust

Brief Explanation of Physical Properties

The K 30 grade is distinguished from the high K-value grades by its low-viscosity solution and fast dissolution. Its 5 percent solution is as fluid as water; therefore it is easy to pump, spray and spray onto granules, and high-concentration binder solutions can be prepared.

The fact that molecular weight figures differ from manufacturer to manufacturer is not a contradiction but a difference in measurement method. Weight-average, number-average and viscosity-average values come out very different from one another for the same polymer; therefore the method should also be asked about when comparing.

The bulk density stays in the range of about 0.4–0.6 g/mL, and the spherical, hollow particles provide good flowability. The angle of repose of Kollidon 30 is 25–38° and the funnel flow time is 5–7 seconds; the high proportion of fine dust, however, requires attention to dust formation during handling.

The high glass transition temperature provides stability in amorphous solid dispersions. However, the same high value makes hot-melt extrusion difficult; in one study K 30 could not be extruded on its own and required a plasticizer or a high active ingredient load.

The differences between data sheets mostly come from the grade, the measurement condition and the production method. Pharmacopoeial limits are binding lower and upper values; the manufacturer’s typical values, on the other hand, are informational and should be evaluated together with the batch certificate of analysis.


HOW DOES POLYVINYLPYRROLIDONE K 30 WORK AT THE MOLECULAR LEVEL?

The action of Polyvinylpyrrolidone K 30 depends largely on the ability of the carbonyl oxygen in the pyrrolidone ring to form hydrogen bonds. This group bonds with water, alcohols, phenols and carboxylic acids; the apolar backbone of the chain helps it attach to surfaces and apolar regions.

As a tablet binder, the polymer dissolved in the granulation liquid wets the surface of the powder particles. During drying the solvent leaves, the chains remain between the particles and form a hard film bridge, and adhere to fillers such as lactose or cellulose through hydrogen bonds.

The medium-length chains of K 30 spread easily in solution and quickly wet the powder particles. For this reason the granulation liquid is distributed evenly through the mass, and the lumping and consistency increase caused by very long-chain grades are seen much less.

In poorly soluble active ingredients, the polymer acts as a matrix that delays crystallization. The active ingredient binds to the chains through hydrogen bonds; the high glass transition temperature limits the mobility of the molecules, which keeps the amorphous state and increases the dissolution rate. In one study the crystallinity fell from 75.2 percent to 3.1 percent.

In film formation, as the solvent evaporates the chains entangle and build a transparent, hard network. A film that takes up water softens and becomes tacky again; this is the reason for the gloss and hold in hair products and for their weakening in humid conditions.

As a dispersant and colloid protector, the polymer adsorbs onto the surface of pigment, carbon black or carbon nanotubes. The hydrophilic chain loops extending from the surface into the water form a barrier that prevents particles from approaching one another; K 25 and K 30 grades are reported to disperse multi-walled carbon nanotubes well.

In metal nanoparticle synthesis, the oxygen and nitrogen of the pyrrolidone ring coordinate with the metal surface. The polymer binds more strongly to some crystal faces and so directs growth; molecular weight and the polymer-to-metal ratio are among the factors that determine particle size.

In nanosuspensions K 30 adsorbs only weakly to the surface, but it helps form small, narrowly distributed particles during milling. In one study, to give the same viscosity, only 1.76 percent K 90 was needed in place of 9.5 percent K 30; this difference shows the effect of chain length on viscosity.

The hydrogen bonds formed with phenolic substances explain why the polymer binds polyphenols in DNA extraction protocols from plant tissue, binds tea and coffee dyes in oral care, and limits dye transfer in laundry.

The sensitivity of the carbons next to the nitrogen in the chain to oxidation is the molecular-level reason for hydroperoxide formation during storage. The peroxides formed can damage sensitive active ingredients in pharmaceuticals and food; for this reason they are decisive in grade selection.


IN WHICH SECTORS IS POLYVINYLPYRROLIDONE K 30 USED?

Because it is soluble, non-ionic and low in viscosity, it has a wide field of use. The main sectors and functions are below.

Pharmaceuticals

It is used as a tablet, capsule and granule binder, a solid dispersion carrier for poorly soluble active ingredients, a suspension stabilizer, a film coating component, and an excipient in sugar-coating suspensions, eye drops and transdermal systems.

Cosmetics and personal care

It is found as a film former and thickener in hair gels, mousses, pump sprays and styling lotions; as a binder in colored cosmetics such as mascara and lipstick; as an emulsion stabilizer in creams and lotions; and as a dispersant in hair dyes.

Oral care

In toothpastes and mouthrinses it is an excipient that binds the stains left by tea, coffee and similar dyes and gives a lubricating feel in oral products. In one manufacturer document, levels of 1 and 2 percent were tested.

Adhesives

It serves as a binder and tackifier in glue sticks, remoistenable tapes, envelope and stamp adhesives and water-based systems.

Paint, ink and coatings

It is a pigment and carbon black dispersant in water-based inks, a component that helps dye uptake in coatings of inkjet papers, and a pigment stabilizer.

Membranes and filtration

It is a pore-forming and hydrophilizing additive in the casting solution of hemodialysis, ultrafiltration and microfiltration membranes.

Detergents and cleaning

It is used in laundry and dishwashing detergents as a component that reduces dye transfer and soil redeposition; its effectiveness depends on the detergent and the dye type.

Batteries and electronic materials

It is used in electrode slurries to disperse carbon nanotubes, carbon black and cathode material and to keep the slurry viscosity low.

Nanomaterial synthesis

It is a surface coating agent for stabilizing, directing the growth of and dispersing metal nanoparticles such as silver, gold and platinum.

Ceramics and textiles

It is found as a binder and dispersant in ceramic slurries, and as an auxiliary that improves dye uptake and antistatic properties in synthetic fibers.

Agriculture

It is used as a binder and complexing agent in seed coatings and plant protection products; it holds the active ingredient on the seed or leaf surface.

Biotechnology and laboratory

It is found in plant DNA and RNA isolation as a polyphenol remover, as a component of Denhardt’s solution and as a microscopy medium.

Food and beverages

Use is very limited. E 1201 is an additive permitted only in certain food supplement tablets and sweetener tablets; for beer and wine clarification, not soluble PVP but cross-linked PVPP is used.

For each of these fields, the grade, documentation and regulatory compliance should be evaluated separately.


IS POLYVINYLPYRROLIDONE K 30 USED IN COSMETIC, FOOD AND PHARMACEUTICAL APPLICATIONS?

Cosmetic applications

Yes. It is known as PVP in cosmetics; the main uses of products such as Luviskol K 30 are hair gels, wet-look gels, mousses, pump sprays and liquid styling preparations. It is a film former that gives gloss and hold.

The manufacturer’s document states that it gives high clarity in water-based gels, is compatible with carbomer-type thickeners and tends to bind with basic dyes. Since a higher molecular weight gives a stronger hold, higher K-value grades are also considered in formulas that need a firmer hold.

The Cosmetic Ingredient Review (CIR) has found vinylpyrrolidone polymers safe for cosmetic use. Even so, product-based safety assessment, the residual monomer limit and the final product legislation are the manufacturer’s responsibility.

In oral care it is used as a stain binder in toothpastes and mouthrinses. Because it is hygroscopic, hold on hair may decrease in humid air; for this reason it is also used together with vinyl acetate copolymers or carbomer for humidity resistance.

Food applications

To a limited extent. Polyvinylpyrrolidone is registered in the EU as a food additive under the code E 1201; however, the permitted use is limited to food supplement tablets and sweetener tablets. It cannot be added directly to every food.

In its 2020 evaluation EFSA concluded that an acceptable daily intake was not needed; JECFA, on the other hand, set a value of 0–50 mg/kg body weight in 1986. Quality, residual monomer and impurity limits are defined in the additive specifications.

The substance used for clarification in beer and wine is the insoluble PVPP, known by the code E 1202. It is used as a processing aid and prevents haze by binding phenolic compounds; it is not the same substance as soluble povidone such as K 30.

Pharmaceutical applications

Yes. K 30 is among the most common grades of povidone, which has monographs in the European, American and Japanese pharmacopoeias. It is found as a binder in tablets and capsules, a solubilizer in liquids, a stabilizer in suspensions and an excipient in eye drops.

It is used as a carrier in solid dispersions to improve the bioavailability of poorly soluble active ingredients. In an eye drop patent, povidone K 30 is used at 1–3 percent, with a preferred level of about 2 percent, together with polyvinyl alcohol.

In pharmaceutical use, the grade, residual monomer, peroxide and nitrite level are important; some manufacturers offer nitrite-tested and low-peroxide grades. Giving high-molecular-weight grades by injection is not considered appropriate. Povidone allergy is rare.

The use of a chemical in one sector does not mean it can be used in other sectors. For pharmaceutical, food and cosmetic applications, the grade, documents and legal conditions should be confirmed separately with the supplier.


INDUSTRIAL APPLICATIONS OF POLYVINYLPYRROLIDONE K 30

Its industrial value comes from its fast dissolution in water and in many solvents, its low-viscosity solution and its compatibility with a large number of substances. The headings below describe the function, the reasons for preference and the limits for each application.

Tablet and capsule production

In wet granulation it is used as a binder, typically at 2–5 percent of the tablet weight. Examples in the manufacturer’s document include 3 percent in a lactose and dicalcium phosphate mixture in high-shear granulation, and 5 percent as a 20 percent aqueous solution in a fluid bed.

In one study, increasing the K 30 level in paracetamol tablets from 2 percent to 4 percent markedly raised the hardness and also lengthened the disintegration time. Very high levels can slow dissolution; the alternatives named are hydroxypropyl cellulose, copovidone and hypromellose.

Solid dispersion and solubility enhancement

Poorly soluble active ingredients are combined with K 30 by solvent evaporation, kneading or co-milling. In a ketoprofen study, active ingredient to polymer ratios of 1:1, 1:3, 1:5 and 1:9 were tried, and dissolution efficiency rose as the polymer increased.

In a gliclazide study, the 1:5 ratio and the solvent evaporation method raised solubility about 2.5-fold and lowered crystallinity from 75.2 percent to 3.1 percent. The manufacturer’s document states that for a dissolved solid solution the polymer must mostly be taken in excess relative to the active ingredient.

Hot-melt extrusion

Because of its high glass transition temperature, K 30 is a polymer that is difficult to extrude on its own. In a hot-melt extrusion study, the glass transition temperature was found to be about 149 °C, the polymer was reported to start decomposing at around 175 °C, and it could not be extruded without a plasticizer or a high active ingredient load.

A suitable plasticizer or a high active ingredient ratio helps lower the working temperature. In this application, polymers that are easier to process, such as copovidone, are also considered in place of K 30.

Hair and skin care

Levels of 3–10 percent in hair gels and 1–4 percent in hair sprays are cited. The polymer is stable in the pH 3–7 range and dissolves in alcohol–water mixtures.

In humid conditions the hold may decrease; in this case use together with a vinyl acetate copolymer or carbomer is considered, and 1–3 percent glycerin is considered against brittleness and flaking. Because of its tendency to bind with basic dyes, compatibility should be tested in colored products.

Oral care

It has been tested at levels of 1–2 percent in toothpastes and mouthrinses. It is reported to improve the removal of tea, coffee and red wine stains and to reduce staining caused by cetylpyridinium chloride, chlorhexidine and tin.

Since the effect depends on the other components and on pH, it should be tested separately in each formula.

Adhesives

It is used as a binder in glue sticks, remoistenable systems and water-based adhesives. In a glue stick patent, K 30 is present at 12.2 percent, together with 4.5 percent sodium stearate and 4 percent glycerin.

Its low viscosity makes it easier to reach a high solids content. Because the film may soften in a humid environment, storage conditions are important. Polyvinyl alcohol, dextrin and acrylic dispersions are alternatives.

Water-based ink and coating

It makes the dispersion of pigment and carbon black easier and helps the dispersion stability of water-based inks. The chains attached to the surface prevent the particles from approaching one another.

In systems where water resistance is important, the solubility of the polymer is a limitation; in this case cross-linking or copolymers are considered. The alternatives are acrylic dispersants, polyvinyl alcohol and cellulose derivatives.

Battery electrodes and carbon nanotube dispersion

It is used as a dispersant in cathode slurries and in the dispersion of carbon nanotube conductive additives. An industry source states that K 25 and K 30 grades gave lower resistance and a more homogeneous dispersion in multi-walled nanotubes than K 17 and K 90.

An example is given in which polymer is added at about 1.25 percent of the nanotube mass. Because it is hygroscopic, the electrode moisture should be monitored; the alternatives are PVDF, carboxymethyl cellulose and polyvinyl alcohol.

Membrane and filtration

The polymer added to the casting solution of membranes such as polyethersulfone adjusts the viscosity and helps pore formation during precipitation. As the amount of polymer increases, the viscosity and the pore structure of the casting solution change.

The portion remaining in the membrane makes the surface hydrophilic. For durability, the washing out of the polymer from the membrane should be monitored; the alternatives are polyethylene glycol and some other hydrophilic polymers.

Detergent and laundry care

Vinylpyrrolidone-based polymers bind the dye released into the wash water and limit its transfer to other fabrics. In one study, a mixture of Polyvinylpyrrolidone and chitosan gave good results on reactive, basic and sulfur dyes and remained weaker on acid and direct dyes.

The effect depends on the detergent composition and the dye type; in the same study the polymer was not seen to change stain removal performance significantly. Copolymers of vinylpyrrolidone and vinylimidazole are also used for this purpose.

Nanomaterial synthesis

It is a surface coating and stabilizing agent in silver nanoparticle synthesis. In one study, polymers of 10, 29 and 55 kDa and polymer to silver molar ratios between 1:1 and 5:1 were compared; K 30 lies in the middle of this molecular weight range.

Molecular weight and ratio affect particle size and stability. The coating polymer remains on the surface after synthesis and may require washing.

Laboratory and biotechnology

In plant DNA and RNA isolation it binds polyphenols and prevents contamination of the nucleic acids. It is a component of Denhardt’s solution.

Here the product should be chosen in analytical or molecular biology grade. As alternatives, cross-linked PVPP or activated carbon can be used; the choice depends on the tissue type and the protocol.

Povidone-iodine

The polymer is a carrier that holds iodine and releases it gradually. In this way the irritancy of iodine is reduced. Low K-value grades are mostly cited for this purpose; in one patent, povidone-iodine was prepared with polymers of K 10–20.

Efficacy depends on the free iodine level, the contact time and the organic load. The alternatives are chlorhexidine, alcohols and other iodophor systems.


CONSIDERATIONS IN THE USE OF POLYVINYLPYRROLIDONE K 30

Polyvinylpyrrolidone K 30 is a polymer that is widely regarded as non-hazardous but that requires attention in terms of quality and handling. The main points to be taken into account in use:

•    The K-value must be written correctly: an order should not be placed with the polymer name alone; the required grade and range, such as K 30 or K 29/32, should be stated clearly; the K 30 ranges of different manufacturers differ from one another by small amounts

•    The grade should be determined according to the application: pharmaceutical, food, cosmetic and technical grades differ in residual monomer, peroxide and impurity limits; 100 ppm is given for residual monomer in cosmetic grade and 10 ppm in the pharmacopoeia

•    The product must be protected from moisture: because it is hygroscopic it takes up water in an opened package, cakes and its glass transition temperature falls; the package must be closed immediately after use

•    When preparing a solution, the powder should be added slowly under stirring: if it is added quickly it gels on the surface and forms undissolved lumps; warm water at about 30–50 °C speeds up dissolution

•    Peroxide formation must be taken into account: peroxides may increase during storage; for active ingredients sensitive to oxidation, low-peroxide grades, oxygen-barrier packaging and handling under nitrogen should be preferred

•    The choice of additives can change the results: in one study ascorbic acid was found to increase the peroxide effect, while propyl gallate and EDTA reduced oxidative degradation; compatibility should be tested separately in each formula

•    It must not be used together with strong oxidizers and strong bases: oxidizers degrade the chain and may form by-products; for this reason the product must be kept away from such substances

•    Aqueous solutions are open to microbial growth: for solutions to be kept, a preservative must be used or the solution must be prepared fresh; mold is reported to form in acidic and dilute solutions

•    Compatibility with anionic polymers must be tested: when used together with anionic polymers such as carbomer, the pH and the order of addition may affect clarity and consistency

•    Dust accumulation must be prevented: fine dust can form a combustible dust mixture in air; sparks and sources of static electricity must be avoided, equipment must be grounded, and cleaning with compressed air must not be done

•    Dust must not be inhaled and contact with the eyes must be avoided. Dust may be irritating; safety goggles, gloves and suitable respiratory protection where dust is generated must be used

•    Environmental impact must be taken into account. The polymer is not readily biodegradable, but it is not considered harmful to aquatic organisms in SDSs; solutions and waste must be disposed of according to local legislation

•    The regulatory status must be verified. For pharmaceutical, food, cosmetic and contact-material uses, the declaration of conformity and the level of documentation must be checked separately

This information is for general information purposes; it does not replace product-specific SDS and TDS documents.


INITIAL FORMULATION APPROACHES FOR POLYVINYLPYRROLIDONE K 30

The approaches in this section are short starting examples showing how the product can be evaluated in the pharmaceutical, oral care and ink fields. Since Polyvinylpyrrolidone K 30 is a low-risk polymer, the levels are given as approximate percentages.

The examples are not verified commercial recipes, production instructions or final formulas that comply with legislation. The levels are starting points for preliminary laboratory trials, and the total of each formula is 100 percent.

The result varies with the active ingredient and other components used, with pH, temperature and humidity conditions. In every application, technical evaluation, quality and regulatory checks must be carried out, and the levels must be reviewed by specialists.

EXAMPLE 1: ASSESSMENT OF THE EFFECT OF THE ACTIVE INGREDIENT:POLYMER RATIO ON THE DISSOLUTION RATE IN A SOLID DISPERSION OF A POORLY SOLUBLE ACTIVE INGREDIENT

Purpose: To monitor how crystallinity, dissolution rate and physical stability change as the level of Polyvinylpyrrolidone K 30 increases in a solid dispersion prepared by solvent evaporation.

Starting approach (on a solids basis):
Model active ingredient (poorly soluble in water): about 16.7 percent
Polyvinylpyrrolidone K 30: about 83.3 percent

Application approach:
•    The active ingredient and the polymer are dissolved in a common solvent (for example ethanol); the solution is stirred until clear.
•    The solvent is removed in a rotary evaporator, the residue is removed by vacuum drying, and the mass is ground and sieved.
•    The active ingredient:polymer ratio is tried in the range of 1:1, 1:3, 1:5 and 1:9; for each ratio, a physical mixture with the same active ingredient is also prepared.
•    Crystallinity by X-ray diffraction and DSC, dissolution rate by the paddle method and stability after storage in a humid environment are compared.
•    Because the polymer is hygroscopic, the samples are stored in dry, closed containers.
•    Ventilation is provided for solvent vapors and dust; ethanol is kept away from ignition sources.

EXAMPLE 2: ASSESSMENT OF THE EFFECT OF THE POLYMER LEVEL IN A MOUTHRINSE ON STAIN BINDING IN A TEA STAIN MODEL AND ON MOUTHFEEL

Purpose: To monitor the effect of the level of Polyvinylpyrrolidone K 30 in a mouthrinse on stain binding, clarity, consistency and mouthfeel.

Starting approach:
Polyvinylpyrrolidone K 30: about 2.0 percent
Glycerin: about 7.0 percent
Poloxamer 407 (flavor solubilizer): about 0.8 percent
Sodium benzoate: about 0.2 percent
Flavor: about 0.2 percent
Sodium saccharin: about 0.05 percent
Purified water: about 89.75 percent

Application approach:
•    The polymer is dissolved in water under stirring; glycerin and sodium benzoate are added.
•    The flavor is premixed with poloxamer 407 in a separate container and added to the clear mixture; saccharin is added.
•    The polymer level is varied in the range of about 1–2 percent.
•    Stain binding on tea-stained model surfaces, solution clarity, consistency, taste and mouthfeel are compared.
•    Compatibility with other product components, for example cationic antimicrobials, and pH are also tested separately.
•    A safety assessment and compliance with the relevant legislation must be carried out separately for the final product.

EXAMPLE 3: ASSESSMENT OF THE EFFECT OF THE POLYMER LEVEL ON DISPERSION STABILITY IN A CARBON BLACK DISPERSION FOR WATER-BASED INK

Purpose: To monitor the effect of the level of Polyvinylpyrrolidone K 30 in a water-based carbon black dispersion on particle size, viscosity and sedimentation stability.

Starting approach:
Carbon black pigment: about 5.0 percent
Polyvinylpyrrolidone K 30: about 1.5 percent
Glycerin: about 5.0 percent
Preservative: about 0.3 percent
Purified water: about 88.2 percent

Application approach:
•    The polymer is dissolved in water; glycerin and preservative are added.
•    The pigment is wetted gradually under high-shear mixing and finely ground in a bead mill or by a similar method.
•    The polymer level is varied in the range of about 15–60 percent relative to the pigment (about 0.75–3.0 percent of the mixture).
•    Particle size, viscosity and sedimentation after holding at 40 °C are observed; the viscosity increase with a higher K-value grade is compared.
•    Density, gloss and water resistance are evaluated on the dried film.
•    Carbon black dust must not be inhaled; a dust mask, goggles and gloves are used.


SIMILAR PRODUCTS AND ALTERNATIVES TO POLYVINYLPYRROLIDONE K 30

When determining an alternative, function, solubility, moisture behavior, film properties, regulation and cost should be evaluated together; the aim is not merely to choose another polymer.

POLYVINYLPYRROLIDONE K 30 AND LOW K-VALUE GRADES (K 12, K 15, K 17)

Low K-value grades have shorter chains; their solutions are more fluid, their films more brittle and their binding power lower. They are preferred in fields that require a low molecular weight, such as povidone-iodine and parenteral products.

K 30 stands at a more balanced point between binding power and processability of the solution. The low K-value grade stands out in systems that require a very high concentration and a low-viscosity solution, and K 30 in applications that require strong binding.

POLYVINYLPYRROLIDONE K 30 AND POLYVINYLPYRROLIDONE K 90

K 90 has a much longer chain; it gives higher binding power, adhesion strength and film toughness. In one nanosuspension study, 9.5 percent K 30 or only 1.76 percent K 90 was needed to obtain the same viscosity.

On the other hand, K 90 solutions are thick and dissolve more slowly; processing can become difficult in applications such as spraying and granulation liquid. For this reason K 30 is more often chosen as a binder, and K 90 in the role of tackifier and thickener.

POLYVINYLPYRROLIDONE K 30 AND COPOVIDONE

Copovidone is a copolymer made of vinylpyrrolidone and vinyl acetate units and is sold under names such as Kollidon VA 64 and Luviskol VA. Manufacturers state that, compared with povidone, it is less hygroscopic, more plastic and has a lower glass transition temperature.

These properties are advantages for tablet compression, film coating, hot-melt extrusion and hair hold in a humid environment. K 30, on the other hand, is preferred where higher binding power and solubilizing power are required and in water-based systems.

POLYVINYLPYRROLIDONE K 30 AND POLYVINYL ALCOHOL

Polyvinyl alcohol is also a water-soluble, film-forming and adhesive polymer. It generally gives higher mechanical strength and barrier properties; its dissolution, however, may require heating.

In adhesives, coatings and electrode binders the two polymers are used together: polyvinyl alcohol provides adhesion, and K 30 provides flexibility and wetting. Pure polyvinyl alcohol does not replace the solubilizing and complexing function of K 30.

POLYVINYLPYRROLIDONE K 30 AND POLYETHYLENE GLYCOL

Polyethylene glycol (PEG) is a water-soluble synthetic polyether; it is used as a plasticizer, solvent and solid dispersion carrier. Its low molecular weight types are liquid or waxy and show no binding power.

Glycerin or PEG 400 can be added to K 30 films as a plasticizer. Polyethylene glycol is an easily processed carrier that melts at a low temperature; K 30, with its higher glass transition temperature, stands out in preserving the amorphous state.

POLYVINYLPYRROLIDONE K 30 AND CELLULOSE DERIVATIVES

Hypromellose (HPMC) and hydroxypropyl cellulose (HPC) are cellulose ethers used as tablet binders, film coatings and gelling agents. They can swell in water and form gel structures and sustained-release matrices.

While K 30 dissolves quickly and binds quickly, cellulose derivatives are less hygroscopic and suitable for controlled release. In nanosuspension studies these polymers are compared with grades such as K 30 as stabilizers; the choice varies with the active ingredient.

POLYVINYLPYRROLIDONE K 30 AND CROSPOVIDONE

Crospovidone is cross-linked, water-insoluble PVPP. It is a disintegrant that swells in water and breaks up tablets quickly; it also prevents haze by retaining polyphenols in beer and wine.

It does not show the binding, film-forming and solubilizing functions of soluble K 30. For this reason the two substances may be present together in the same formula but do not replace each other.

POLYVINYLPYRROLIDONE K 30 AND VINYLPYRROLIDONE COPOLYMERS

Copolymers of vinylpyrrolidone with monomers such as vinylimidazole, vinyl acetate or dimethylaminoethyl methacrylate give special functions according to the target use. They are used in dye transfer inhibition, hair care and cationic care products.

No alternative is an exact substitute in every system. In each case performance testing and regulatory checks must be carried out, and the K-value and grade must be evaluated together.


QUALITY CONTROL AND PURCHASING CRITERIA FOR POLYVINYLPYRROLIDONE K 30

Polyvinylpyrrolidone products sold under the same CAS number differ from one another in K-value, grade, moisture, residual monomer and peroxide level. For this reason, for K 30 it should first be clarified whether the product is of pharmaceutical, food, cosmetic or technical grade.

The main parameters that can be evaluated in quality control and the purchasing process:

•    K-value: The measured value is compared with the nominal value of 30 on the label. The Ph.Eur. and USP define the acceptance range as 90–108 percent of the nominal value, which comes to roughly 27.0–32.4. Supplier ranges, on the other hand, may be narrower, such as 27.0–32.0 and 29.0–32.0, or wider, such as 28–34 and 26–34

•    Molecular weight: Manufacturers give ranges of roughly 38,000–56,000 (BASF), roughly 45,000 (Luviskol) or roughly 58,000 (Plasdone K-29/32) for K 30. The difference comes from the measurement method and the type of average; the value that is binding for the target application is the K-value

•    Nitrogen content: On the dry basis the pharmacopoeial limit is 11.5–12.8 percent. The method and the range should be clarified with the supplier

•    Moisture: At most 5 percent in the pharmacopoeias. Because the product is hygroscopic, the moisture of the batch at delivery and after opening should be asked about separately

•    Residual monomer: The Ph.Eur. and USP limit for N-vinylpyrrolidone is at most 10 ppm. In cosmetic and technical grades, higher limits such as 100 ppm may appear in manufacturer documents; the limit should be requested in writing before ordering

•    Peroxide: A limit of at most 400 ppm as hydrogen peroxide is defined. Low-peroxide (LP) grades are available for active ingredients sensitive to oxidation; the batch result should be verified from the certificate of analysis

•    Aldehyde, hydrazine and other impurities: Aldehyde is defined as about 500 ppm, hydrazine at most 1 ppm, 2-pyrrolidone at most 3 percent and formic acid at most 0.5 percent

•    Sulfated ash and heavy metals: Sulfated ash at most 0.1 percent and heavy metals at most 10 ppm. EU food additive specifications give at most 2 mg/kg for lead

•    pH: In the Ph.Eur. a range of 3.0–5.0 is given in a 5 percent solution. In cosmetic grade, wider ranges such as 3.0–7.0 are used for a 10 percent solution; values should not be compared without knowing the measurement concentration

•    Color and clarity: The solution should be clear and light in color. In cosmetic grade there are limits such as a Hazen color of at most 40 APHA in a 3.5 percent solution

•    Appearance: It should be a white to slightly yellowish, free-flowing powder. Caking, darkening or moisture stains point to a quality problem

•    Particle size and bulk density: BASF gives the bulk density of Kollidon 30 as 0.45–0.55 g/mL and, in sieve analysis, at most 40 percent below 50 µm and at most 5 percent above 250 µm; these are characteristic values, not specifications

•    Viscosity: The viscosity of a 5 percent solution at 25 °C is about 2.5–3 mPa·s; as the solution concentration rises, the consistency increases rapidly

•    Grade types: The same manufacturer may offer pharmaceutical, cosmetic and technical grades as well as nitrite-tested (NT) and low-peroxide (LP) types; which type is required should be written clearly in the order

•    Documents: Batch-based certificate of analysis, current SDS, TDS, pharmacopoeial compliance (Ph.Eur., USP, JP), declaration of conformity with food additive specifications, REACH information and, where necessary, pharmaceutical excipient quality documents

•    Packaging and batch: For BASF, a 25 kg carton with a bag liner and a 50 kg HDPE drum are given as examples; small packs such as 100 g and 500 g are available in laboratory quantities. The batch number and production date should be checked

•    Shelf life: Varies by manufacturer; 48 months is given for Kollidon 30, 36 months for Luviskol K 30 and 60 months for some laboratory products. The moisture and peroxide level of a product that has been kept for a long time can be retested before use

Binding specifications should be separated from typical values. Typical values are for information; the specification in the contract and the batch results on the certificate of analysis should be taken as the basis.


STORAGE AND TRANSPORT OF POLYVINYLPYRROLIDONE K 30

It is stable in dry, closed packaging; the most important storage factors are moisture, oxygen and heat. Storage conditions should be determined according to these properties.

•    Temperature and place: It is stored in a cool, dry, well-ventilated place, away from heat sources and direct sunlight. Manufacturers mostly specify 10–25 °C or room temperature; the TDS of the grade concerned should be taken as the basis

•    Moisture: At about 80 percent relative humidity the product takes up so much water that it begins to dissolve. The package must be kept tightly closed, and an opened package must be closed immediately

•    Packaging: It should be kept in its original packaging with the labels intact. Packaging with a moisture-barrier inner bag is preferred; for grades sensitive to oxidation, special oxygen-barrier packaging can be used

•    Oxygen and peroxide: During long-term storage the peroxide level may rise. For sensitive applications, low-peroxide grades and handling under nitrogen are considered

•    Incompatible substances: It should be stored separately from strong oxidizers and strong bases. It should be kept away from heat sources, flammable materials and ignition sources

•    Dust and fire safety: Fine dust can form a combustible dust mixture in air. Dust accumulation must be prevented, equipment must be grounded, and cleaning with compressed air must not be done

•    Stacking: Bags and drums should be stacked evenly on pallets, crushing and tearing prevented, and damaged packaging set aside

•    Solutions: Aqueous solutions should be stored in closed containers; if they are to be kept, a preservative should be added or the solution prepared fresh. Mold may grow in acidic and dilute solutions

•    Shelf life: Varies by manufacturer; retest conditions are found in the supplier’s documents

•    Transport: Safety data sheets state that the solid product is not regulated as dangerous goods in road, air and sea transport; no UN number or hazard class is assigned

•    Transport classification: The classification may depend on the product form and the date of the document. Solutions, complexes such as povidone-iodine and ready-made mixtures may be assessed differently. Before shipment, the supplier’s current SDS and the applicable legislation should be taken as the basis

•    During transport: Package integrity should be preserved, the product kept away from moisture and rain, and not loaded together with oxidizing substances


SAFETY INFORMATION ON POLYVINYLPYRROLIDONE K 30

In manufacturers’ safety data sheets Polyvinylpyrrolidone K 30 is mostly not classified as a hazardous substance. One SDS carries a combustible dust warning and, because of the 2-pyrrolidone present in the component at about 2 percent, an eye irritation statement; the statements may differ from supplier to supplier.

The information below is for general information purposes and does not replace the manufacturer-specific safety data sheet. The SDS of each supplier should be taken into account.

Main safety topics:

•    Hazard classes: In many SDSs it is not classified as a hazardous substance under GHS and CLP. Some documents carry a combustible dust warning; the classification should be checked by grade and supplier

•    Acute toxicity: The oral LD50 in rats is reported as very high, about 100,000 mg/kg; another document gives 40,000 mg/kg in mice. Its wide use in food and pharmaceuticals is consistent with this low toxicity

•    Skin and eye contact: It generally does not irritate the skin. In case of eye contact, rinse with plenty of water for at least 15 minutes and seek medical help if irritation persists

•    Inhalation: Dust may irritate the respiratory tract; with repeated and prolonged high dust exposure, the lung tissue may be affected. The person should be taken to fresh air and medical help sought if symptoms persist

•    Ingestion: The mouth should be rinsed, plenty of water given, and a health facility or poison information center (114 in Türkiye) contacted if discomfort continues

•    Fire and explosion: Hard to ignite in bulk; however, a fine dust cloud may ignite with a spark. One SDS gives an auto-ignition temperature above 400 °C and a lower explosion limit of 15 g/m³. In a fire, water spray, alcohol-resistant foam, dry chemical or carbon dioxide are used; combustion products are carbon oxides and nitrogen oxides

•    Reactivity: Stable under the recommended conditions. May react violently with strong oxidizers and strong bases; it is hygroscopic

•    Personal protective equipment: Safety goggles, gloves and protective clothing must be used. Where dust is generated, respiratory protection with a particulate filter and local exhaust are recommended

•    Spills: It should be swept up without generating dust and collected in a separate container; compressed air must not be used. Wetted polymer makes surfaces slippery; after a spill the area should be washed with plenty of water

•    Monomer: N-vinylpyrrolidone, used in production, is classified as a category 2 carcinogen. Residual limits in product grades are kept low; workplace limits are applied separately at facilities that work with the monomer

•    Environment: The polymer is not readily biodegradable; it is not considered harmful to aquatic organisms in SDSs. It should not be discharged into streams and sewers in high loads

•    Waste: Residual product and contaminated packaging must be disposed of according to local legislation; recycling or controlled incineration is considered where appropriate

•    Exposure and help: If symptoms persist, or if there is doubt about ingestion, inhalation or eye contact, a health facility should be contacted with the product label and the SDS


WHAT SHOULD BE CONSIDERED WHEN BUYING POLYVINYLPYRROLIDONE K 30?

To choose the right product, the identity must first be clearly determined. Because polyvinylpyrrolidone can be confused with cross-linked PVPP, copovidone, povidone-iodine and the monomer N-vinylpyrrolidone, and K 30 can be confused with neighboring grades such as K 25 and K 90, a request that only says “PVP” is insufficient.

In a request, the product name Polyvinylpyrrolidone K 30, the CAS number 9003-39-8 and, if needed, range information such as K 29/32 should be stated together.

The main points to consider when buying:

•    Intended use and regulation: It should be clarified whether the product will be used in a pharmaceutical, food, cosmetic or technical application; the regulatory conditions of the relevant country should be confirmed with the supplier

•    K-value range: Manufacturers’ K 30 ranges differ from one another; the accepted lower and upper limits should be determined according to the sensitivity of the application

•    Grade: Pharmaceutical, food, cosmetic and technical grades may differ in residual monomer, peroxide and level of documentation. A cosmetic-grade document may state that it is not suitable for pharmaceutical use

•    Technical specifications: K-value, nitrogen, moisture, residual monomer, peroxide, aldehyde, heavy metals, pH and particle size should be requested clearly

•    Form: The requirement for powder or aqueous solution should be stated; dissolution rate and dust formation depend on this choice

•    Packaging and logistics: Net quantity, moisture-barrier packaging, pallet arrangement and storage conditions should be determined

•    Batch consistency: The certificates of analysis, K-values and physical appearance of consecutive batches should be compared

•    Shelf life: The production date and remaining shelf life of the delivered product should be asked about

•    Documents: SDS, TDS, COA, pharmacopoeial compliance, REACH information and, where necessary, food and cosmetic declarations of conformity should be requested

•    Supplier’s technical support: Support with selecting the grade suited to the application, preparing solutions and storage should be evaluated

•    Origin and manufacturer: Transparency of manufacturer information and traceability may be requested

•    Total cost of supply: Besides the unit price, the K-value range, grade, dose, packaging, storage and waste management costs should be calculated together

A price comparison should not be made on the price per kilogram alone; the K-value range, grade, level of documentation and supply security should also be taken into account.


SUPPLY OF POLYVINYLPYRROLIDONE K 30 FROM ATAMAN KİMYA

Polyvinylpyrrolidone K 30 is a product evaluated as a tablet binder, a solid dispersion carrier, a film former in hair care, and a dispersant in inks and coatings. On the ATAMAN KİMYA website, Polyvinylpyrrolidone K 30 appears on product pages under the names PVP K 30, Polyvinylpyrrolidone K 30 (PVP K30), Polyvinylpyrrolidone PVP K30, Povidone K30, Povidone K-30 and PVP K 30 Polyvinylpyrrolidone.

Companies planning to purchase are advised to clarify the grade suited to the intended use, the K-value range, the technical specifications, the regulatory conditions and the necessary documents before ordering.

Companies that want information on supply from ATAMAN KİMYA can request information on product suitability, current supply status, packaging options and a price quotation by sharing their fields of use and technical needs.

The current stock status, origin, grade, K-value range, packaging, transport classification and the regulatory conditions for the intended use of the product should be confirmed with ATAMAN KİMYA before ordering.

Sharing the following information in a quotation request makes it easier to evaluate the right product quickly:

•    Sector of use and final application

•    Requested product name or grade: Polyvinylpyrrolidone K 30, PVP K30, Povidone K-30 or equivalent

•    Required K-value range

•    Requested form: powder or solution

•    Moisture, residual monomer, peroxide and impurity limits

•    Grade: pharmaceutical, food, cosmetic or technical

•    Regulatory status for the intended use

•    Process or application method used

•    Estimated order quantity

•    Required packaging type

•    Requested technical documents

•    TDS or COA information of the current product, if available


FREQUENTLY ASKED QUESTIONS ABOUT POLYVINYLPYRROLIDONE K 30

What is Polyvinylpyrrolidone K 30?
It is the grade of a water-soluble, non-ionic synthetic polymer made from the N-vinylpyrrolidone monomer that has a K-value of about 30 and a medium molecular weight. It is used as a tablet binder, film former, solubilizer and dispersant in pharmaceuticals, cosmetics, inks and adhesives.

What does Polyvinylpyrrolidone K 30 mean?
The name denotes the polymer formed by chaining vinyl units that carry a pyrrolidone ring, and the fact that its K-value is about 30. In pharmacopoeial and regulatory language the same substance appears under the names povidone K 30 or K 29/32.

What is the CAS number of Polyvinylpyrrolidone K 30?
The CAS number is 9003-39-8. This number covers all K-values; grades such as K 30 and K 90 are sold under the same number, so the K-value must be stated separately in the order.

What is the EC / EINECS number of Polyvinylpyrrolidone K 30?
There is no single EC number for the polymer. Some documents give 201-800-4, the number of the monomer N-vinylpyrrolidone; the CAS number and the K-value are taken as the basis for identifying the product.

What is the chemical formula of Polyvinylpyrrolidone K 30?
The polymer, whose repeat unit is C₆H₉NO, is shown as (C₆H₉NO)ₙ. The molecular weight of the repeat unit is 111.14 g/mol; for K 30 manufacturers give the average molecular weight in the range of roughly 38,000–58,000.

What does the K-value mean in Polyvinylpyrrolidone K 30?
The K-value is a number calculated from the viscosity of the polymer in dilute solution and related to the average molecular weight. For K 30 the acceptance range in the pharmacopoeias is 90–108 percent of the nominal value; that is, roughly 27.0–32.4.

What is the INCI name of Polyvinylpyrrolidone K 30?
The INCI name is PVP; the K-value is not stated in the INCI name. The existence of an INCI name does not mean that the product can automatically be used in cosmetics; the grade and legal conditions should be evaluated separately.

Is Polyvinylpyrrolidone K 30 used in cosmetics?
Yes. It is used as a film former in hair gels, hair sprays and mousses, and as a binder and dispersant in colored cosmetics. Vinylpyrrolidone polymers have been found safe by the CIR for cosmetic use.

Is Polyvinylpyrrolidone K 30 used in food or pharmaceuticals, and does it have an E code?
Yes, to a limited extent. It is registered in the EU as a food additive under the code E 1201, and the permitted use is limited to food supplement and sweetener tablets. In pharmaceuticals it is a common excipient with a pharmacopoeial monograph.

What is the difference between Polyvinylpyrrolidone K 30 and Polyvinylpyrrolidone K 90?
The difference lies in chain length. K 90 has a much higher molecular weight; its solution is thicker and its binding and adhesion stronger. K 30 gives a more fluid solution and is easier to process in applications such as granulation liquid.

What is Polyvinylpyrrolidone K 30 used for?
It is used for binding, film forming, solubilizing, delaying crystallization, dispersing pigments and particles, and colloid protection. Tablets, solid dispersions, hair products, oral care, adhesives, inks and membranes are the main examples.

In which sectors is Polyvinylpyrrolidone K 30 used?
It is used in pharmaceuticals, cosmetics and personal care, oral care, adhesives, inks and coatings, membranes and filtration, detergents, textiles, battery materials, nanomaterial synthesis, agriculture and laboratories.

How does Polyvinylpyrrolidone K 30 perform its binding function?
It dissolves in the granulation liquid, wets the powder particles and, during drying, forms film bridges between the particles. The hydrogen bonds formed by the carbonyl groups provide adhesion to fillers such as lactose and cellulose.

What is Polyvinylpyrrolidone K 30 good for?
It gives hardness to tablets, hold and gloss to hair products, tack to adhesives, pigment stability to inks, and pores and hydrophilicity to membranes; it helps increase the dissolution rate of poorly soluble active ingredients.

How does Polyvinylpyrrolidone K 30 work in hair styling products?
As the solvent evaporates it forms a transparent film on the hair strands; the strands stick to one another and take shape. Because it is hygroscopic, hold may decrease in humid air; use together with vinyl acetate copolymers or carbomer is then considered.

Is Polyvinylpyrrolidone K 30 soluble in water?
Yes, very well; a level of 100 mg/mL is given in one manufacturer document. It also dissolves in ethanol, isopropanol, methanol, glycerol, propylene glycol and chloroform; it does not dissolve in ether, toluene and hydrocarbons. The powder should be added slowly under stirring.

How much Polyvinylpyrrolidone K 30 is used as a tablet binder?
A range of 2–5 percent of the tablet weight is mostly used. The actual amount is determined by trials according to the active ingredient, the granulation method and the target hardness; in one study going from 2 percent to 4 percent increased tablet hardness.

Is Polyvinylpyrrolidone K 30 a hazardous substance?
In most SDSs it is not classified as a hazardous substance. Its acute oral toxicity is very low. Fine dust can form combustible dust and may slightly irritate the eyes; work should be done with suitable protective equipment and without generating dust.

Why does Polyvinylpyrrolidone K 30 absorb moisture and why can it form peroxides?
Since the carbonyl groups bind water by hydrogen bonding, it is hygroscopic. The carbons next to the nitrogen, on the other hand, tend to react with oxygen; hydroperoxides can form in storage. For this reason moisture-barrier packaging and low-peroxide grades are important.

Is Polyvinylpyrrolidone K 30 registered under REACH?
Polymers are excluded from the registration obligation under REACH; the monomer N-vinylpyrrolidone, on the other hand, is registered. The current regulatory status of the product and the supplier’s notifications should be confirmed with the supplier.

What is the physical appearance of Polyvinylpyrrolidone K 30?
It is a white to slightly yellowish, odorless or very faintly odorous, hygroscopic, free-flowing powder. Particle size varies with the manufacturer and the production method; some grades are sold as an aqueous solution.

What is the UN number of Polyvinylpyrrolidone K 30?
Safety data sheets state that the solid product is not regulated as dangerous goods; therefore it has no UN number or hazard class. For solutions or complex products the situation should be checked from the supplier’s SDS.

Why are residual monomer and peroxide important in Polyvinylpyrrolidone K 30?
Residual N-vinylpyrrolidone is a monomer with a carcinogen classification; its limit in pharmaceutical grade is 10 ppm. Peroxides, on the other hand, can degrade active ingredients sensitive to oxidation; for this reason the limits should be verified from the certificate of analysis.

What does the price of Polyvinylpyrrolidone K 30 depend on?
The price varies with the grade (pharmaceutical, food, cosmetic or technical), K-value range, form, packaging, order quantity, origin, certification, monomer and peroxide limits, raw material costs and logistics conditions.

Is there an alternative to Polyvinylpyrrolidone K 30?
Yes. Copovidone, polyvinyl alcohol, polyethylene glycol, hypromellose, hydroxypropyl cellulose and vinylpyrrolidone copolymers may be alternatives depending on the application. None is a direct substitute in every system.

How should Polyvinylpyrrolidone K 30 be stored?
It should be stored in a cool, dry, well-ventilated place, in its closed original packaging, away from moisture, heat and oxidizing substances. An opened package should be closed immediately and dust accumulation prevented.

Which documents should be requested when buying Polyvinylpyrrolidone K 30?
SDS, TDS and the batch-based COA are the basic documents. In addition, pharmacopoeial compliance, REACH information and a supplier declaration for pharmaceutical, food or cosmetic use may be requested.

Which technical specifications are important when buying Polyvinylpyrrolidone K 30?
K-value range, nitrogen content, moisture, residual monomer, peroxide, aldehyde, pH, solubility, particle size, bulk density, grade type, shelf life and packaging are important.


POLYVINYLPYRROLIDONE K 30 – TECHNICAL SUMMARY

Chemical name: Poly(1-vinylpyrrolidin-2-one); 1-ethenylpyrrolidin-2-one homopolymer, K-value about 30

Common name: Polyvinylpyrrolidone K 30, Polyvinyl pyrrolidone K 30, Povidone K 30, PVP K 30, Kollidon 30, Plasdone K-29/32, Luviskol K 30

CAS No: 9003-39-8

EC / EINECS No: There is no single number for the polymer; some documents show 201-800-4, the number of the monomer

Molecular formula: (C₆H₉NO)ₙ

Molecular weight: 111.14 g/mol for the repeat unit; average molecular weight in manufacturer documents roughly 38,000–58,000 for K 30

Chemical class: Synthetic, non-ionic, water-soluble N-vinyllactam polymer

Physical appearance: White to slightly yellowish, odorless or very faintly odorous, hygroscopic, free-flowing powder; some grades as an aqueous solution

Main properties: Soluble in water, ethanol, methanol, glycerol and chloroform; insoluble in ether, toluene and hydrocarbons. Bulk density about 0.4–0.6 g/mL, true density about 1.2 g/cm³, glass transition temperature about 150–171 °C depending on the manufacturer, viscosity of a 5 percent solution about 2.5–3 mPa·s. Nitrogen content 11.5–12.8 percent; moisture at most 5 percent

Main functions: Binder, film former, solubilizer, dispersant, colloid protector, crystallization retarder, tackifier

Important fields of application: Tablet and solid dispersion formulations, hair and oral care, adhesives, water-based inks and coatings, membranes, detergents, battery materials, nanomaterial synthesis, laboratory, povidone-iodine

Critical parameters for quality control: K-value range, nitrogen, moisture, residual N-vinylpyrrolidone, peroxide, aldehyde, heavy metals, pH, particle size and documents appropriate to the grade

Storage: In a cool, dry, ventilated area, in closed moisture-barrier original packaging; away from moisture, heat and oxidizing substances; shelf life 36–60 months depending on the manufacturer

Regulation: Not classified as a hazardous substance in most SDSs; fine dust can form combustible dust. Permitted in the EU for limited food use as E 1201, its INCI name is PVP, and it has a pharmacopoeial monograph; cross-linked PVPP (E 1202) is a separate substance. Conditions of use and transport should be confirmed with the supplier and current legislation.
 

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