What is the European Pharmacopoeia (Ph. Eur.) 7.0?
It is an official pharmacopoeia (medicinal product code) compiled by the Council of Europe, which establishes quality standards for medicinal products, excipients, biological products, and certain components of medical devices. The pharmacopoeia defines the official standards and analytical methods used in the manufacture, authorization, and quality control of medicinal products. For this reason, particularly in the context of biocidal products, the determination of Povidone-iodine (PVP-I) is carried out in accordance with this pharmacopoeia.
Povidone-iodine is a complex of iodine and polyvinylpyrrolidone (PVP). It contains free iodine (I₂) and bound iodine forms. The main component responsible for its antimicrobial effect is the amount of free iodine. It is particularly favored as an active ingredient in wound cleansing solutions, surgical hand antiseptics, and surface disinfectants.
In this context, we support the “Determination of Povidone-Iodine in Biocidal Products”.
Why is the determination of Povidone-Iodine necessary?
For biocidal products, quality control, efficacy assessment, and safety assurance are verified. Through the determination of Povidone-Iodine, it is possible to:
- determine the total iodine content in the product.
- confirm the antimicrobial efficacy by measuring the free iodine content.
- verify compliance with the specifications of the European Pharmacopoeia (Ph. Eur. 7.0).
What analytical methods are available according to European Pharmacopoeia 7.0?
a) Identity Tests
- Spectrophotometric Analysis (Absorbance measurement at 288 nm)
- Color Test with Potassium Iodide
- PVP Verification via IR Spectroscopy
b) Determination of Total Iodine Content
- The sample is dissolved in potassium iodide solution.
- The liberated iodine is measured by titration with sodium thiosulfate solution.
- Permissible Range: 9.0 % – 12.0 % (on a dried basis).
c) Determination of free iodine
- The sample solution is prepared.
- A direct titration with sodium thiosulfate is performed.
- The free iodine content is a critical parameter for the product's biocidal efficacy.
d) Purity and other tests
- Limit of heavy metals
- Moisture content (loss on drying)
- pH control
- Determination of available iodine
The importance of Povidone-Iodine determination in biocidal products
Thanks to the determination of Povidone-Iodine according to the European Pharmacopoeia 7.0:
- product registration procedures are supported,
- quality assurance is ensured,
- user safety is guaranteed.
NanoTest Deutschland offers analysis and determination services for Povidone-Iodine (PVP-I) according to the methods of the European Pharmacopoeia (Ph. Eur. 7.0 and current editions) for use in biocidal products. Contact us for specific tests such as Povidone-Iodine to receive regulatory-compliant, reliable, and rapid analytical support for manufacturers and importers.