K30, PVP-K60, PVP-K90, E1201, 9003-39-8

Polyvinylpyrrolidone, Polyvinyl Pyrrolidone, Polyvidone, Crospovidone, PVP, PVPP, PVP-K30, PVP-K60, PVP-K90, E1201, 9003-39-8

POLYVINYLPYRROLIDONE (PVP)
PRODUCT IDENTIFICATION INFORMATION

CHEMICAL STRUCTURE

Polyvinylpyrrolidone (PVP)

CH—CH₂
/
/
O=C N—CH₂
| /
CH₂—CH₂—CH₂

Molecular Formula: (C₆H₉NO)n
SMILES: Not applicable (polymer)
InChI: Not applicable (polymer)
Structure: Linear polymer composed of N-vinylpyrrolidone monomers linked through the vinyl group; The pyrrolidone ring provides polarity and hydrophilicity; Pendant lactam rings are responsible for complexation and hydrogen bonding.

SECTION 1: CHEMICAL IDENTITY AND DESCRIPTION

SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES

SECTION 3: PVP GRADES AND K-VALUES

The K-value is a characteristic parameter for PVP, derived from relative viscosity measurements. It is related to molecular weight and solution viscosity. Higher K-values indicate higher molecular weight and higher viscosity .

Note: Molecular weight values vary depending on measurement method (weight average, viscosity average, number average). The table shows typical ranges .

SECTION 4: PVP FAMILY - COMPARISON

SECTION 5: CHEMICAL PROPERTIES AND REACTIVITY

SECTION 6: PRODUCTION METHODS

Method 1: Free Radical Polymerization (Aqueous Solution)

Reaction: n(C₆H₉NO) → (C₆H₉NO)n

Description: N-vinylpyrrolidone monomer is polymerized in aqueous solution using free radical initiators (e.g., hydrogen peroxide, ammonium persulfate, or AIBN); Polymerization is carried out at controlled temperature (50-80°C); The polymer solution is spray-dried to obtain a fine powder; Molecular weight (K-value) is controlled by initiator concentration and reaction conditions .

Method 2: Bulk Polymerization

Process: Monomer + Initiator → Polymerization in bulk

Description: N-vinylpyrrolidone is polymerized in bulk (without solvent) using thermal or photoinitiation; Requires careful temperature control due to exothermic reaction; Product is cooled, ground, and processed.

Method 3: Suspension Polymerization (for Crospovidone)

Process: Monomer + Crosslinker + Initiator → Crosslinked polymer beads

Description: N-vinylpyrrolidone is polymerized in suspension with a crosslinking agent (e.g., divinylbenzene); Forms crosslinked, insoluble polymer beads; Used for crospovidone production (superdisintegrant) .

SECTION 7: FUNCTIONAL PROPERTIES AND MECHANISM OF ACTION

SECTION 8: MAIN APPLICATION AREAS

SECTION 9: QUALITY SPECIFICATIONS

SECTION 10: TOXICOLOGICAL PROFILE

SECTION 11: GHS CLASSIFICATION AND LABELING

GHS Classification (in accordance with CLP and UN GHS):

SIGNAL WORD: NONE (not classified as hazardous)

Hazard Pictograms: NONE

Hazard Statements (H-Codes): Not classified as hazardous under GHS regulations.

NFPA 704 Hazard Classification:

SECTION 12: PRECAUTIONARY STATEMENTS (P-CODES)

SECTION 13: FIRST AID MEASURES

SECTION 14: FIREFIGHTING MEASURES

SECTION 15: STORAGE AND SHELF LIFE

SECTION 16: PACKAGING OPTIONS

SECTION 17: TRANSPORT INFORMATION

SECTION 18: REGULATORY STATUS

SECTION 19: OTHER NAMES AND SYNONYMS

SECTION 20: SUMMARY TABLE

SECTION 21: CRITICAL WARNINGS AND BEST PRACTICES

CRITICAL WARNINGS:

• Not classified as hazardous under GHS. Non-toxic, non-irritating, non-carcinogenic. FDA-approved for pharmaceutical use .

• Hygroscopic – absorbs moisture from air. Store in tightly closed, moisture-proof containers. Protect from high humidity.

• Dust may cause mechanical irritation to eyes, skin, and respiratory system. Use appropriate dust control measures.

• Combustible (organic material). Keep away from open flames and high heat. Dust cloud may form explosive mixture.

• Light sensitive. Protect from direct sunlight and UV light.

• K-value selection is critical for formulation performance. Higher K-values = higher molecular weight = higher viscosity and stronger film formation .

• PVP family distinction: Povidone (soluble binder), Crospovidone (insoluble superdisintegrant), Copovidone (copolymer with different properties) .

• Incompatibilities: Strong oxidizing agents, strong acids (degradation).

• N-Vinylpyrrolidone monomer content strictly controlled in pharmaceutical grades (≤10 ppm) .

BEST PRACTICE RECOMMENDATIONS:

Pharmaceuticals (Binder): Use as tablet binder (K30 or K90); Typical concentration 1-5%; Wet granulation or direct compression; Improves tablet hardness and friability; Provides good adhesion between particles; Ensure compliance with USP/Ph.Eur. specifications.

Pharmaceuticals (Solubilizer / Bioavailability Enhancer): Use in solid dispersions for poorly soluble drugs; Forms complexes with hydrophobic drug molecules; K25-K30 grades typically used; Improves dissolution rate and bioavailability; Critical for BCS Class II/IV drugs.

Pharmaceuticals (Crospovidone - Superdisintegrant): Use crospovidone (crosslinked PVP) as superdisintegrant; Rapid water uptake and swelling; No gel formation; Typical use 1-5%; XL (standard) and XL-10 (micronized) grades; Particle size selection affects disintegration time .

Cosmetics & Personal Care: Use as film former and fixative in hair sprays (4-6% PVP in ethanol); Wave sets use 1-2% polymer; Forms hard, glossy films; Compatible with other cosmetic ingredients; INCI: PVP.

Pharmaceutical Coatings: Use as coating agent for tablets; Forms clear, glossy, oxygen-permeable films; Provides protection and improved appearance; Can be used with plasticizers for flexibility.

Food Industry: Use as food additive E1201; Clarifying agent for beer and wine; Stabilizer for food products; Ensure compliance with food-grade specifications.

Handling: Use in well-ventilated areas; Avoid dust formation; Use dust masks (N95/FFP2) when handling powder; Use gloves and safety goggles.

Personal Protective Equipment: Dust mask (N95/FFP2 or higher), safety goggles, protective gloves (nitrile, neoprene). Not required for solution handling.

Hygiene: Wash hands thoroughly after handling; Do not eat, drink, or smoke while using.

Storage: Store in tightly closed, moisture-proof containers; Store in a cool, dry, well-ventilated area; Protect from moisture, rain, sunlight, and high humidity; Opened packages should be resealed immediately; Shelf life: 24-36 months under proper conditions.

Spill Management: Sweep or vacuum (HEPA) and place in suitable sealed container; Avoid dust formation; Do not allow entry into drains or waterways.

Disposal: Dispose of in accordance with local, regional, and national regulations; Non-hazardous waste; Can be incinerated in compliance with regulations.

SPECIAL NOTE ON K-VALUE AND GRADE SELECTION:

K-value is the most important parameter for PVP selection :

• K12, K15, K17: Low molecular weight (3,000-16,000). Use for solubilization, dispersancy, crystallization inhibition. Low viscosity solutions. Suitable for syrups and liquid formulations.

• K25, K30: Medium molecular weight (30,000-80,000). Most commonly used grades. K30 is the industry standard for tablet binding. Good balance of binding strength and solution viscosity. Suitable for granulation, direct compression, and film formation.

• K60, K90: High molecular weight (270,000-1,570,000). High viscosity solutions. Use for thickening, suspension stabilization, and high-strength films. Suitable for sustained-release formulations.

• K120: Very high molecular weight (>2,100,000). Very high viscosity. Used in specialty applications requiring maximum viscosity.

• Selection criteria: Desired viscosity, binding strength, film properties, and application requirements.

SPECIAL NOTE ON CROSPOVIDONE (SUPERDISINTEGRANT):

Crospovidone is crosslinked PVP with distinct properties :

• Structure: Crosslinked polymer; Practically insoluble in water.

• Function: Superdisintegrant for tablets and capsules.

• Mechanism: Rapid water absorption; Swells without gel formation; Breaks tablets apart quickly.

• Grades: XL (standard particle size), XL-10 (micronized for faster disintegration).

• Usage: 1-5% of tablet weight.

• Advantages: Fast disintegration; No gel layer; Compatible with most formulations.

• Applications: Orally disintegrating tablets; Fast-release formulations; Capsule disintegrant.

SPECIAL NOTE ON POVIDONE-IODINE:

PVP forms a stable complex with iodine:

• Product: Povidone-iodine (PVP-I).

• Use: Broad-spectrum antiseptic and disinfectant.

• Mechanism: PVP slowly releases iodine; Iodine provides antimicrobial activity.

• Applications: Antiseptic solutions, ointments, surgical scrubs, wound dressings.

• Advantages: Water-soluble; Non-staining (dilute); Long-lasting antimicrobial action; Less irritating than pure iodine.

LEGAL DISCLAIMER:
The information provided in this document is based on our current knowledge and experience and is presented in good faith. However, as all conditions of use are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only. Users are responsible for testing the suitability for their own applications. For complete safety, storage, use, handling, waste, and regulatory compliance information, please refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier.