For professionals in the pharmaceutical, medical, and chemical industries, procuring Povidone-Iodine (CAS 25655-41-8) requires a thorough understanding of its specifications and the importance of relevant certifications. This compound's efficacy as a broad-spectrum antimicrobial agent makes it a critical raw material, and ensuring its quality is paramount. As a dedicated manufacturer and supplier, we provide this guide to help buyers make informed purchasing decisions.

Key Product Specifications to Consider:

  • Appearance: Povidone-Iodine typically appears as a free-flowing, reddish-brown to yellow-brown amorphous powder. Consistent color and particle consistency are indicators of quality.
  • Available Iodine Content: This is a critical parameter, usually specified within a range (e.g., 9.0%-12.0% for 10% solutions, or 19.0%-22.0% for 20% solutions). A reliable supplier will provide precise lot-specific data on available iodine, which directly correlates to its antimicrobial potency.
  • Purity: While Povidone-Iodine is a complex, its overall purity and the absence of undesirable by-products are crucial. Suppliers should indicate purity levels, often specified as >95% or meeting USP/EP/BP standards.
  • Loss on Drying: This measures the moisture content, which affects the stability and handling of the powder. Lower moisture content is generally preferred.
  • Residue on Ignition/Sulphated Ash: This indicates the inorganic impurity content. Lower values are indicative of higher purity.
  • Heavy Metals and Arsenic Salt: Essential for pharmaceutical and food-grade applications, these limits must be strictly controlled and verified through testing.
  • pH Value: For 10% aqueous solutions, the pH typically ranges from 1.5 to 5.0, indicating its acidic nature in solution.

Essential Certifications for Buyers:

  • GMP (Good Manufacturing Practices): Crucial for pharmaceutical applications, GMP certification ensures that the product is consistently produced and controlled according to quality standards.
  • CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia): This certification demonstrates that the Povidone-Iodine complies with the European Pharmacopoeia standards, facilitating market access in Europe.
  • DMF (Drug Master File): Filing a DMF with regulatory authorities like the US FDA allows pharmaceutical companies to reference the manufacturer's detailed information about the drug substance, streamlining their own regulatory submissions.
  • Kosher and Halal: For products catering to specific dietary or religious markets, these certifications are essential.
  • ISO Certifications (e.g., ISO 9001): Demonstrates a commitment to quality management systems throughout the manufacturing process.

When engaging with a potential supplier, always request comprehensive documentation. A manufacturer that readily provides detailed CoAs, technical data sheets (TDS), and Material Safety Data Sheets (MSDS), alongside valid certifications, is a strong indicator of reliability and commitment to quality. We, as an experienced manufacturer, are equipped to supply Povidone-Iodine that meets these exacting standards. We invite you to inquire about our product specifications and certifications to ensure you are sourcing the best possible raw material for your critical applications.