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Povidone Iodine, Polyvinyl Pyrrolidone-iodine, PVP Iodine, PVP-I, 25655-41-8

Povidone Iodine, Polyvinyl Pyrrolidone-iodine, PVP Iodine, PVP-I, 25655-41-8

POVIDONE IODINE (PVP-IODINE)

PRODUCT IDENTIFIER INFORMATION

Parameter Information
Product Name Povidone Iodine
Chemical Name Polyvinylpyrrolidone-Iodine Complex (Iodophor)
CAS Number 25655-41-8
Alternative CAS Number 74500-22-4 (high-iodine variant)
Molecular Formula C6H10I3NO
Molecular Weight 492.87 g/mol

SECTION 1: CHEMICAL IDENTITY AND DESCRIPTION

Parameter Information
Chemical Name (IUPAC) 1-Ethenyl-2-pyrrolidinone, homopolymer, compound with iodine
Synonyms Povidone Iodine, PVP-I, PVP Iodine, Polyvinylpyrrolidone-Iodine Complex, Provodin, Betadine
Trade Names Betadine, Pharmadine, Efo-dine, Provodin, Povidex, Isodine
CAS Number (Standard) 25655-41-8
CAS Number (High-Iodine Variant) 74500-22-4
MDL Number MFCD00084483
Molecular Formula C6H10I3NO
Molecular Weight 492.87 g/mol
Chemical Class Iodophor complex (polyvinylpyrrolidone + iodine)
Available Iodine Content 9-12% (standard), up to 14% (high-iodine variant)
Physical State (20°C) Solid (yellowish-brown to reddish-brown amorphous powder)
Odor Slight characteristic odor
Chemical Character Stabilized iodine complex with controlled iodine release

SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES

Property Value Test Method
Appearance Yellowish-brown to reddish-brown amorphous powder Visual
Odor Slight characteristic odor Olfactometric
Molecular Weight 492.87 g/mol Calculated
Melting Point 300°C (decomposes) DSC
Boiling Point 217.6°C (at 760 mmHg) Calculated
Flash Point 93.9°C ASTM D93
Vapor Pressure (25°C) 0.132 mmHg ASTM D2879
pH (Aqueous Solution) Acidic (typically 2.0 - 4.0 for 10% solution) pH Meter
Solubility in Water Soluble General Method
Solubility in Ethanol Soluble General Method
Solubility in Ether Insoluble General Method
Solubility in Chloroform Insoluble General Method
Solubility in Acetone Insoluble General Method
Solubility in Carbon Tetrachloride Insoluble General Method
Stability Stable under dry, closed conditions; light and moisture sensitive  

SECTION 3: COMPARISON OF POVIDONE IODINE AND ELEMENTAL IODINE

Property Povidone Iodine (CAS 25655-41-8) Elemental Iodine (CAS 7553-56-2)
Chemical Structure Iodophor complex (Polyvinylpyrrolidone + Iodine) Pure diatomic iodine (I2)
Molecular Weight ~365-493 g/mol (depending on complex ratio) 253.81 g/mol
Iodine Content ~9-14% (controlled release) 100% iodine
Toxicity Low – safe for skin and mucous membranes High – irritating and volatile
Solubility Soluble in water, ethanol, methanol, isopropanol Slightly soluble in water; soluble in organic solvents
Physical Form Yellowish-brown amorphous powder or gel Dark violet crystals or granules
Application Type Topical antiseptic, wound care, surgical preparation Chemical synthesis, analytical reagent, iodized salt, feed additive
Pharmaceutical Use Direct skin/mucous membrane application API intermediate or tincture component
Laboratory Use Microbiological disinfectant, in vitro rinsing Redox titration, iodine value determination
Storage Stability Stable under dry, closed conditions Sensitive to oxidation and sublimation
Release Mechanism Controlled iodine release Immediate iodine availability
Regulatory Status Finished product component Chemical intermediate

SECTION 4: SECTORAL USE COMPARISON

Sector Povidone Iodine Applications Elemental Iodine Applications
Pharmaceutical Antiseptic gels, surgical prep, gynecological wash solutions API synthesis, tincture iodine
Hygiene and Disinfection Skin cleansers, wound disinfectants Raw material for iodophor production
Laboratory and Clinical In vitro rinsing, microbiological testing Analytical reagent, iodine value test
Cosmetic Active ingredient in skin hygiene products Not typically used directly
Medical Equipment Disinfection of surgical instruments and metal surfaces Used in sterilization formulations
Agriculture and Feed Not direct; via iodophor formulations Micronutrient additive in animal feed
Food Industry Not direct; used in antiseptic packaging Iodized salt production
Chemical Industry Iodophor synthesis Halogenation, catalyst, intermediate
Trade and Customs CAS 25655-41-8 / 74500-22-4 for antiseptic products CAS 7553-56-2 / 12190-71-5 for technical iodine classification

SECTION 5: CAS NUMBER REFERENCE TABLE

CAS Number Compound Type Notes
25655-41-8 Povidone Iodine (standard) Most common iodophor antiseptic; USP/EP compliant
74500-22-4 Povidone Iodine (variant) Higher iodine content; used in gels and surgical formulations
7553-56-2 Elemental Iodine (granule) Pure iodine; used in synthesis, analysis, and iodized salt
12190-71-5 Elemental Iodine (pure) High-purity analytical grade; used in laboratory and pharmaceutical synthesis

SECTION 6: SYNONYMS BY CAS NUMBER

Povidone Iodine (CAS 25655-41-8 / 74500-22-4):

Synonym / Trade Name Context / Notes
Povidone Iodine INCI name, most common international designation
PVP-I Polyvinylpyrrolidone-Iodine abbreviation
Povidon Iyot Turkish spelling
Povidon Iyodin Alternative Turkish spelling
Polivinil Prolidon Iyot Turkish chemical variant
Provodin Trade name
Betadine Widely recognized trademark
Efo-dine Regional trade name
Pharmadine Brand used in hospital-grade antiseptics
PVP Iodine Common catalog name
Polyvinylpyrrolidone-Iodine Complex Structural description
Hydrogen triiodide compound Used in CAS 74500-22-4 descriptions
1-Ethenyl-homopolymer iodine compound Chemical description
Iodine compound Simplified chemical description

Elemental Iodine (CAS 7553-56-2 / 12190-71-5):

Synonym / Trade Name Context / Notes
Iodine General name
Molecular Iodine Structural reference (I2)
Diiodine Official chemical name
Prilled Iodine Bead form used in industry
Iodine Crystals Describes physical appearance
Iodine Powder Commercial form
Iodine (USP/ACS) Pharmaceutical and analytical grade
Iodine Solution Standard Substance Analytical reagent grade
Iodin German variant spelling
HX968 Supplier-specific catalog code
Sublimed Iodine Purified form
Double Sublimed Iodine Double-purified form

SECTION 7: FUNCTIONAL PROPERTIES AND MECHANISM OF ACTION

Property Description
Antimicrobial Effect Broad-spectrum microbicidal activity against bacteria, viruses, fungi, protozoa, and spores
Controlled Release Mechanism PVP polymer acts as a carrier, gradually releasing free iodine (I2) upon contact with skin or mucous membranes
Residual Activity Provides prolonged antimicrobial effect due to sustained iodine release
Low Irritation PVP carrier minimizes the irritating effects of free iodine on skin and mucous membranes
Non-Staining Unlike tincture iodine, PVP-I solutions are less staining and easily washable
Water Solubility Complex formation with PVP enables excellent water solubility, unlike elemental iodine
Deiodinization Not Required Post-use deiodinization with ethanol is not required, unlike elemental iodine preparations
Non-Corrosive Does not corrode surgical instruments or metal surfaces at recommended concentrations

SECTION 8: PRIMARY APPLICATION AREAS

Application Area Function Typical Concentration
Antiseptic Microbicidal disinfectant for skin and mucous membranes 7.5-10% solution
Wound Care Prevents infection in cuts, burns, and abrasions 10% ointment/cream
Surgical Preparation Pre-operative skin disinfection 7.5-10% scrub/solution
Gynecological Products Vaginal antiseptic wash solutions and suppositories 10% solution
Ophthalmic Preparations Antiseptic in eye drops 0.4-2.5% solution
Nasal Preparations Antiseptic in nasal drops 1-5% solution
Topical Creams Antiseptic in dermatological formulations 5-10% cream
Medical Equipment Disinfection of surgical instruments 2.5-10% solution
Laboratory Microbiological disinfectant, in vitro rinsing 1-10% solution
Oral Care Mouthwash and gargle for oral hygiene 0.5-1% solution

SECTION 9: QUALITY SPECIFICATIONS (USP/EP GRADE)

Parameter Specification Test Method
Appearance Yellowish-brown to reddish-brown amorphous powder Visual
Odor Slight characteristic odor Olfactometric
Identification (IR) Conforms to reference standard USP/EP Monograph
Available Iodine (Titratable I2) 9.0 - 12.0% (on dried basis) Iodometric Titration
Loss on Drying (105°C, 3 hours) ≤ 8.0% Gravimetric
pH (10% aqueous suspension) 1.5 - 5.0 pH Meter
Iodide (I-) ≤ 6.0% (calculated as KI) Potentiometric Titration
Residue on Ignition ≤ 0.1% Gravimetric (600°C)
Heavy Metals (as Pb) ≤ 20 ppm ICP-MS / USP <231>
Lead (Pb) ≤ 2 ppm ICP-MS
Arsenic (As) ≤ 3 ppm ICP-MS
Mercury (Hg) ≤ 1 ppm ICP-MS
Cadmium (Cd) ≤ 1 ppm ICP-MS
Nitrogen Content 9.5 - 11.5% (on dried basis) Kjeldahl
Total Microbial Count ≤ 100 CFU/g USP <61>
Yeast and Mold ≤ 10 CFU/g USP <61>
Pseudomonas aeruginosa Negative in 1g USP <62>
Staphylococcus aureus Negative in 1g USP <62>

SECTION 10: TOXICOLOGICAL PROFILE

Parameter Value
Acute Oral Toxicity (LD50, Rat) > 5,000 mg/kg (low toxicity due to PVP complex)
Acute Dermal Toxicity (LD50, Rabbit) > 2,000 mg/kg
Skin Irritation Mild irritant (significantly less than elemental iodine)
Eye Irritation Mild-moderate irritant
Respiratory Irritation Powder inhalation may cause mechanical irritation
Skin Sensitization Low sensitization potential
Carcinogenicity Not classified (IARC, NTP)
Mutagenicity Negative in standard tests
Reproductive Toxicity No known adverse effects at therapeutic doses
Chronic Toxicity Long-term topical use generally well-tolerated
Thyroid Function Prolonged use on large surface areas may affect thyroid function due to iodine absorption

SECTION 11: GHS CLASSIFICATION AND LABELING

GHS Classification (compliant with 1272/2008/EC):

Hazard Class Category H-Statement
Skin Irritation Category 2 H315
Serious Eye Damage/Irritation Category 2 H319
Specific Target Organ Toxicity (STOT - SE) Category 3 H335
Chronic Aquatic Toxicity Category 3 H412

Signal Word: WARNING

Hazard Pictograms:

┌─────────┐
│   !     │  GHS07 - Exclamation Mark
└─────────┘

Hazard Statements (H-Codes):

Code Statement
H315 Causes skin irritation
H319 Causes serious eye irritation
H335 May cause respiratory irritation
H412 Harmful to aquatic life with long lasting effects

Precautionary Statements (P-Codes):

Code Statement
P261 Avoid breathing dust/fume/gas/mist/vapors/spray
P264 Wash hands thoroughly after handling
P271 Use only outdoors or in a well-ventilated area
P280 Wear protective gloves/eye protection/face protection
P302+P352 IF ON SKIN: Wash with plenty of water and soap
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
P312 Call a POISON CENTER/doctor if you feel unwell
P403+P233 Store in a well-ventilated place. Keep container tightly closed
P501 Dispose of contents/container to an approved waste disposal facility

SECTION 12: FIRST AID MEASURES

Exposure Route Action to Take
Inhalation Move to fresh air. Seek medical attention if respiratory irritation persists.
Skin Contact Wash with plenty of water and soap. Seek medical attention if irritation develops.
Eye Contact Rinse immediately with plenty of water for at least 15 minutes. Remove contact lenses if present. Seek medical attention if irritation persists.
Ingestion Rinse mouth with water. Drink plenty of water. Do NOT induce vomiting. Seek medical attention if you feel unwell.

SECTION 13: FIREFIGHTING MEASURES

Parameter Information
Fire Hazard Low fire hazard; may release toxic iodine vapors when heated
Hazards During Fire Toxic iodine (I2) vapors, hydrogen iodide (HI), nitrogen oxides (NOx), carbon monoxide (CO)
Suitable Extinguishing Media Water spray, alcohol-resistant foam, dry chemical powder, CO2
Special Protective Equipment Self-contained breathing apparatus (SCBA), full protective clothing
Special Precautions Cool containers exposed to fire with water mist. Prevent firefighting water from entering the environment.

SECTION 14: STORAGE AND SHELF LIFE

Parameter Information
Storage Conditions Cool (15-25°C), dry, well-ventilated area; protected from light and moisture
Container Requirements Tightly closed, light-resistant containers
Keep Away From Heat, direct sunlight, moisture, strong reducing agents, ammonia, ammonium salts
Shelf Life 36 months (unopened original packaging under appropriate storage conditions)
Stability Note Stable under dry, closed conditions; moisture may cause caking and iodine loss

SECTION 15: PACKAGING OPTIONS

Packaging Type Quantity Material
Aluminum foil pouch 1 kg Laminated aluminum
Aluminum foil pouch 5 kg Laminated aluminum
HDPE drum (light-protected) 25 kg HDPE
Fiber drum with PE liner 25-50 kg Fiberboard + PE
Plastic jar (light-resistant) 1-5 kg HDPE (amber)

SECTION 16: TRANSPORTATION INFORMATION

Parameter Information
UN Number Not regulated as dangerous goods
Hazard Class Not applicable
Packing Group Not applicable
ADR/RID Not regulated
IMDG Code Not regulated
IATA (Air) Not regulated
Marine Pollutant No
Transport Temperature Ambient (15-25°C)

SECTION 17: ACCIDENTAL RELEASE AND CLEANUP

Parameter Information
Personal Protection Nitrile gloves, safety goggles, dust mask (N95)
Cleanup Methods Sweep up or vacuum dry. Collect in closed, labeled containers. Avoid dust formation.
Environmental Precautions Prevent entry into drains, soil, and surface water.
Waste Disposal According to local/national regulations; incineration at licensed disposal facility.

SECTION 18: REGULATORY STATUS

Region / Authority Status
USA (USP-NF) Official monograph (USP Povidone Iodine)
European Pharmacopoeia Official monograph (Ph. Eur. Povidone Iodine)
USA (FDA) OTC monograph for topical antiseptic use; GRAS for certain food contact applications
European Union Approved active substance in biocidal products (BPR Regulation); cosmetic ingredient
WHO Essential Medicines List Essential medicine as antiseptic and disinfectant
Turkey Registered pharmaceutical active ingredient; cosmetic ingredient
INCI Povidone Iodine (listed cosmetic ingredient)

SECTION 19: OTHER NAMES AND SYNONYMS

Type Name
Chemical Names Povidone Iodine, Polyvinylpyrrolidone-Iodine Complex, PVP-Iodine
Trade Names Betadine, Pharmadine, Provodin, Efo-dine, Povidex, Isodine, Betaseptic
Pharmacopoeia Names Povidone Iodine (USP), Povidonum Iodinated (Ph. Eur.)
Turkish Names Povidon Iyot, Povidon Iyodin, Polivinil Prolidon Iyot
Abbreviated Names PVP-I, PVP Iodine
CAS Number (Standard) 25655-41-8
CAS Number (Variant) 74500-22-4

SECTION 20: COMPARISON WITH OTHER IODINE-BASED ANTISEPTICS

Property Povidone Iodine Tincture Iodine Iodine Solution (Lugol's) Chlorhexidine (for reference)
Active Ingredient PVP-Iodine Complex I2 in Ethanol I2 + KI in Water Chlorhexidine Gluconate
Iodine Content 9-12% 2-7% 1-5% None
Skin Irritation Low Moderate-High Moderate Very Low
Staining Low High Moderate None
Residual Activity Yes (4-6 hours) Limited Limited Yes (6-8 hours)
Antimicrobial Spectrum Broad Broad Broad Good (limited vs. fungi)
Wound Use Yes Not recommended Limited Yes
Mucous Membrane Yes (diluted) No Limited No
Surgical Scrub Yes (gold standard) No No Yes (alternative)

SECTION 21: SUMMARY TABLE

Parameter Value
Product Povidone Iodine (PVP-Iodine)
CAS Number 25655-41-8
Molecular Formula C6H10I3NO
Molecular Weight 492.87 g/mol
Appearance Yellowish-brown to reddish-brown amorphous powder
Available Iodine Content 9-12%
Solubility Soluble in water and ethanol
Primary Function Broad-spectrum topical antiseptic, wound care, surgical preparation
Shelf Life 36 months (unopened original packaging)
GHS Signal Word Warning
Regulatory Status USP/EP monograph, FDA OTC, WHO Essential Medicine

SECTION 22: CRITICAL WARNINGS AND BEST PRACTICES

CRITICAL SAFETY WARNINGS:

  1. Thyroid Function: Prolonged use on large surface areas, especially in patients with pre-existing thyroid conditions, may affect thyroid function due to systemic iodine absorption.

  2. Hypersensitivity: Rare cases of hypersensitivity reactions including anaphylaxis have been reported. Discontinue use if rash, itching, or swelling occurs.

  3. Pregnancy and Lactation: Use during pregnancy and lactation only when clearly needed and under medical supervision. Vaginal use near term should be avoided.

  4. Neonates: Use with caution in neonates and very young infants due to potential for systemic iodine absorption through immature skin.

  5. Lithium Interaction: Patients on lithium therapy should avoid prolonged use as iodine may potentiate lithium's anti-thyroid effects.

  6. Incompatible Materials: Avoid contact with strong reducing agents, ammonia, ammonium salts, alkaloids, and thiosulfates which may inactivate iodine.

BEST PRACTICE RECOMMENDATIONS:

  1. Fresh Preparation: Prepare aqueous solutions fresh or use within recommended period; iodine content may decrease over time.

  2. Proper Dilution: Follow manufacturer's instructions for proper dilution ratios for specific applications (surgical scrub, wound irrigation, etc.).

  3. Contact Time: Allow sufficient contact time (minimum 1-2 minutes for disinfection, 2-3 minutes for surgical preparation) for optimal antimicrobial effect.

  4. Avoid Occlusion: Do not apply under occlusive dressings on large areas to minimize systemic absorption.

  5. Storage: Store in original light-resistant containers; keep tightly closed when not in use.

  6. Quality Verification: Source only from GMP-certified manufacturers; verify available iodine content per pharmacopoeia specifications.

LEGAL DISCLAIMER:

The information provided in this document is presented in good faith based on our current knowledge and experience; however, since all usage conditions are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only and does not constitute medical advice. Users are obligated to test the suitability for their own applications. For complete safety, storage, handling, transportation, disposal, and regulatory compliance information, refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier. This product is not intended to diagnose, treat, cure, or prevent any disease.

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