Product Overview
Pure Piroctone Olamine Powder is a high-purity cosmetic active ingredient widely used in anti-dandruff shampoos, scalp care products, and rinse-off formulations.
It is manufactured by Tobrand under a controlled GMP production system and designed for large-scale commercial cosmetic manufacturing, offering consistent batch stability performance, consistent purity, and regulatory compliance.
The product is supplied with full documentation (COA, MSDS, TDS) to support global cosmetic regulatory requirements.
Technical Specifications
All specifications are tested in Tobrand's in-house analytical laboratory using validated methods including HPLC, ICP-MS, GC-TEA, and pH analysis systems.
|
Parameter Category |
Specification / Test Item |
Standard Limits / Value |
Test Method (Reference) |
|
Physical & Chemical Properties |
Appearance |
White to slightly yellowish crystalline powder |
Visual inspection |
|
Assay (Purity) |
≥ 99.0% |
HPLC |
|
|
Melting Point |
130.0°C – 135.0°C |
Capillary method |
|
|
Loss on Drying |
≤ 0.5% |
Gravimetric (105°C, 2h) |
|
|
Residue on Ignition |
≤ 0.1% |
Sulfated ash method |
|
|
pH Value (1% In Water, 20°C) |
8.5 – 10.0 |
pH Meter |
|
|
Purity & Process Residuals |
Free Ethanolamine |
20.0% – 21.5% |
Titration |
|
Toxicological Impurities |
Heavy Metals (as Pb) |
≤ 10 ppm |
ICP-MS |
|
Arsenic (As) |
≤ 2 ppm |
ICP-MS |
|
|
Lead (Pb) |
≤ 2 ppm |
ICP-MS |
|
|
Nitrosamines |
≤ 50 ppb (or Non-Detected) |
GC-TEA / LC-MS/MS |
|
|
Processing & Solubility |
Water Solubility (20°C) |
Approx. 0.1% (Soluble in surfactant systems) |
Gravimetric |
|
Ethanol Solubility (20°C) |
Soluble (up to 10%) |
Visual clarity |
|
|
Thermal Stability |
Stable up to 80°C (Addition recommended below 45°C) |
R&D Stability Test |
The testing framework is designed not only for compliance checking, but also for impurity risk control and formulation stability validation, ensuring consistency for large-scale cosmetic manufacturing.
Key Performance
High purity of 99.0% or above ensures efficient antimicrobial activity at low dosage levels in personal care formulations.
Strict impurity control maintains nitrosamine levels below 50 ppb, reducing regulatory and formulation risks for global compliance.
Excellent compatibility with surfactant systems allows for clear, sediment-free shampoo and hair care end products.
Shipped directly from dedicated US and European warehouses to shorten lead times and minimize supply chain disruptions.
Recommended Applications & Dosage
Applications: Anti-dandruff shampoos, anti-itch scalp serums, hair conditioners, and premium anti-acne cleansers.
Recommended Dosage: 0.1% – 0.5% for leave-on formulations; 0.5% – 1.0% for rinse-off products.
Formulation Tip: Highly recommended to incorporate during the cooling phase below 45°C for optimal ingredient stability.
Regulatory Compliance & Certification
All certifications are maintained under active audit systems and are not static documents. Compliance is continuously validated through internal quality audits and third-party certification bodies.
|
Compliance Category |
Standard & Certification |
Compliance Status & Deliverables |
|
System Certifications |
ISO 22716:2007 (cGMP) |
Certified / Factory Audit Report Available |
|
ISO 9001:2015 |
Certified / Quality Manual Summary Provided |
|
|
Kosher / Halal |
Certified / Annual Active Certificates Issued |
|
|
Global Market Access |
EU REACH |
Fully Registered / Tonnage Certificate Available |
|
Regulation (EC) No 1223/2009 (Annex V) |
Compliant / Product Safety Dossier Provided |
|
|
US MoCRA (FDA Facility Registered) |
Compliant / Registration Framework Confirmed |
|
|
IECIC Listing |
Listed / Official Compliance Statement Issued |
|
|
Auditing & Dossiers |
GHS Safety Data Sheet |
Maintained / Globally Compliant SDS (PDF) |
|
Cruelty-Free / Vegan / BSE-Free |
Verified / Official Factory Declarations Available |
|
|
SVHC Impurity Control |
Guaranteed / Batch-Specific Statement Provided |
Key regulatory frameworks include EU cosmetic regulation (EC No 1223/2009), REACH registration status, and US MoCRA facility compliance structure, ensuring compatibility with major global cosmetic markets.
Logistics & Supply Chain Capacity
Standard Packaging: 25kg/drum (Industrial standard alignment. Customized commercial outer packaging available upon requested volume).
Local Delivery: Dispatched directly from Tobrand's regional fulfillment centers in the United States and Europe for shortened transit cycles.
Direct Bulk Cargo: Shipped from main ports in China with comprehensive customs clearance documentation.
Transparency & Samples
Sample Support: Free 20g–50g physical samples are available for laboratory evaluation, qualification, and trial batches.
Batch Traceability: Every shipped lot is accompanied by a batch-specific Certificate of Analysis (COA) directly linked to our internal HPLC raw data.
FAQ