📋 CERTIFICATE OF ANALYSIS
Certificate of Analysis
Povidone-Iodine (PVPI) - High Purity Grade
This certificate confirms that the specified product meets the required analytical specifications for pharmaceutical and disinfectant applications.
Product Name
Povidone-Iodine (PVPI)
CAS Number
25655-41-8
Molecular Formula
(C₆H₉NO)ₙ·xI
Chemical Name
1-Vinyl-2-pyrrolidinone polymer, compound with iodine
Batch Number
PVPI-2412-001
Manufacturing Date
June 2025
Retest Date
June 2027
Grade
Pharmaceutical / USP / BP / Ph. Eur.
📊 Analytical Specifications
| Test | Specification | Result | Status |
|---|---|---|---|
| Appearance | Reddish-brown, free-flowing powder | Complies | ✓ Passed |
| Identification A | Starch-iodine blue color reaction | Positive | ✓ Passed |
| Identification B | Brown, dry, non-smearing film | Conforms | ✓ Passed |
| Available Iodine (I) | 9.0% - 12.0% | 10.58% | ✓ Passed |
| Iodide Ion (I⁻) | ≤ 6.6% | 3.60% | ✓ Passed |
| Nitrogen Content (N) | 9.5% - 11.5% | 10.80% | ✓ Passed |
| Loss on Drying | ≤ 8.0% | 3.88% | ✓ Passed |
| Sulfated Ash (Residue on Ignition) | ≤ 0.025% | 0.020% | ✓ Passed |
| pH Value (10% aqueous solution) | 1.5 - 5.0 | 2.8 | ✓ Passed |
| Heavy Metals (as Pb) | ≤ 20 ppm | <20 ppm | ✓ Passed |
🔬 Physical & Chemical Properties
| Property | Value |
|---|---|
| Appearance | Reddish-brown to brownish-yellow powder |
| Odor | Slight characteristic odor |
| Solubility in Water | Completely soluble in cold water |
| Solubility in Ethanol | Soluble |
| Solubility in Ether/Chloroform | Insoluble |
| pH (10% solution) | Acidic (1.5 - 5.0) |
✅ Standards Compliance
| Pharmacopoeia | USP, BP, Ph. Eur., CP |
|---|---|
| Quality System | ISO 9001:2015 Certified Facility |
| GMP Status | GMP Compliant |
🏆 Available PVPI Grades
| Grade | Available Iodine | Iodide Ion | Application |
|---|---|---|---|
| PVPI 10% | 9.0% - 12.0% | ≤ 6.6% | Disinfectant, antiseptic solution, ointments |
| PVPI 20% | 20.0% - 24.0% | ≤ 13.5% | Concentrate for dilution, industrial disinfection |
⚠️ Impurity Profile
| Impurity / Element | Specification | Result |
|---|---|---|
| Arsenic (As) | ≤ 1.5 ppm | <1.5 ppm |
| Heavy Metals (as Pb) | ≤ 20 ppm | <20 ppm |
| Residual Solvents | Meets USP requirements | Complies |
| Iodate (IO₃⁻) | ≤ 4 ppm | <4 ppm |
📦 Packaging Information
| Container Type | HDPE Drums / Fiber Drums with inner liner / Amber Glass Bottles |
|---|---|
| Net Weight | 25 kg / 50 kg / Custom packaging available |
| Storage Condition | Keep in dry, cool, well-ventilated area, away from light and moisture |
| Shelf Life | 24 months from manufacturing date (unopened) |
🦠 Antimicrobial Activity
| Microorganism | Result |
|---|---|
| Staphylococcus aureus | Effective (≥99.9% kill rate) |
| Escherichia coli | Effective (≥99.9% kill rate) |
| Pseudomonas aeruginosa | Effective (≥99.9% kill rate) |
| Candida albicans | Effective (≥99.9% kill rate) |
| Aspergillus niger | Effective (≥99.9% kill rate) |