What is the European Pharmacopoeia (Ph. Eur.) 7.0?
It is an official Pharmacopoeia (Drug Code) established by the Council of Europe, which sets quality standards for pharmaceuticals, excipients, biological products and certain components of medical devices. The pharmacopoeia defines the official standards and methods of analysis used in the manufacture, approval and quality control of drugs. For this reason, the determination of Povidonium iodide (Povidone-iodine, PVP-I) is carried out, especially in the case of biocidal products, taking this pharmacopoeia into account.
Povidonium iodide is a complex of iodine and polyvinylpyrrolidone (PVP). It contains free iodine (I₂) and bound iodine forms. The main ingredient responsible for the antimicrobial effect is the amount of free iodine. It is particularly preferred as an active ingredient in wound cleaning solutions, surgical hand antiseptics and surface disinfectants.
In this context, we support the "determination of povidone iodide in biocide products".
Why is the determination of povidone iodide required?
In the case of biocidal products, the quality control, the determination of the effectiveness and the guarantee of safety are checked. With the determination of povidone iodide:
- the Total Iodine Amount in the product can be determined.
- the antimicrobial effectiveness can be confirmed by measuring the free iodine amount.
- the compliance with the specifications of the European Pharmacopoeia (Ph. Eur. 7.0) can be checked.
What analysis methods are there according to European Pharmacopoeia 7.0?
a) Identity Verifications
- Spectral photometric analysis (absorption measurement at 288 nm)
- Color test with potassium iodide
- PVP verification using IR spectroscopy
b) Determination of total iodine content
- The sample is dissolved in potassium iodide solution.
- The released iodine is measured by titration with sodium thiosulfate solution.
- Permissible range: 9.0% - 12.0% (based on dry matter).
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 biocidal efficacy of the product.
d) purity and other tests
- Limitation of heavy metals
- Moisture content (loss of drying)
- pH control
- Determination of the available iodine
The Importance of the Determination of Povidone Iodide in Biocidal Products
Thanks to the determination of povidone iodide according to the European pharmacopoeia 7.0:
- product approval procedures are supported,
- If quality assurance is guaranteed,
- the safety of the user is guaranteed.
NanoTest Germany offers Analysis and determination services for Povidone iodinate (PVP-I) according to the methods of European pharmacopoeia (Ph. Eur. 7.0 and current expenses) for use in biocidal products. Contact us for specific tests such as Povidone Iodinate to obtain Regulatory, Reliable and Fast Analysis Support for Manufacturers and Importers.