For any chemical compound used in pharmaceutical and medical applications, understanding its specifications is paramount. Povidone-Iodine (PVP-I) is no exception. Its efficacy and safety are intrinsically linked to its purity, chemical identity, and adherence to recognized standards. This article breaks down the key specifications of PVP-I, including its CAS number, purity levels, and essential certifications like USP, BP, and EP, providing insight into why these details are vital for quality assurance and regulatory compliance. Grasping these details enhances the understanding of povidone iodine medical applications.

The Chemical Abstracts Service (CAS) number for Povidone-Iodine is 25655-41-8. This unique identifier is crucial for accurately identifying the compound across scientific literature, regulatory databases, and commercial products. Having a correct CAS number ensures that researchers, manufacturers, and regulatory bodies are all referring to the same substance, preventing confusion and ensuring proper handling and application. This is foundational to understanding povidone iodine antiseptic uses.

Purity is another critical specification. PVP-I is typically available with a purity range, commonly stated as 9.0%-12.0% available iodine. This parameter indicates the concentration of active iodine released from the PVP complex, which directly correlates to its antimicrobial potency. Manufacturers must adhere to strict quality control measures to ensure that the product consistently meets these purity standards. Ensuring the correct purity is fundamental to the benefits of povidone iodine in achieving desired antiseptic effects.

Certifications play a vital role in validating that PVP-I meets the rigorous standards set by major pharmacopoeias. Key certifications include:

  • USP (United States Pharmacopeia): This sets standards for the identity, strength, quality, and purity of medicines, food, and dietary supplements.
  • BP (British Pharmacopoeia): Similar to USP, BP provides comprehensive standards for medicines in the UK.
  • EP (European Pharmacopoeia): This establishes harmonized quality standards for medicines across Europe.
Products certified with these pharmacopoeias, such as ISO 9001, USP, BP, and EP, guarantee a level of quality and safety that is essential for their use in pharmaceuticals and medical devices. Adherence to these standards ensures that the pvp iodine skin disinfection is performed with a reliable product.

The presence of certifications like ISO 9001, DMF (Drug Master File), and GMP (Good Manufacturing Practice) further assures customers of the product's quality, safety, and consistent manufacturing processes. These certifications are often indicative of a supplier's commitment to rigorous quality management systems and regulatory compliance, which are essential when sourcing materials for medical products. Such quality assurance is critical for all povidone iodine medical applications.

In summary, understanding the CAS number, purity levels, and pharmacopoeial certifications of Povidone-Iodine is not merely a technical detail; it is fundamental to ensuring product quality, efficacy, and safety. These specifications provide confidence in the material's suitability for its intended applications, reinforcing the reliable benefits of povidone iodine in healthcare and beyond.