Peroxide value as a further indicator of the shelf life of lipid excipients

IOI Oleo GmbH enjoys an excellent reputation worldwide as a manufacturer of high-quality, lipid-based additives. In order to ensure that we maintain our standards for the highest quality and to comply with the guideline values of national and international pharmacopoeias, we attach great importance to the selection of the raw materials and suppliers we use as well as state-of-the-art production processes at our locations in Germany. In this context, the peroxide value (PV) can be used as a key indicator of the rancidity of lipids and is used by pharmaceutical companies as an indicator of the quality of their excipients.

In our article “Acid value as a central, objective quality factor for lipid excipients” we have already reported on the acid value as an indicator of impurities. The peroxide value is another quality factor that provides information about the freshness and shelf life of lipid excipients.

Many of these pharmaceutical excipients contain unsaturated fatty acids that tend to oxidize. In contact with oxygen, they can form peroxides that lead to rancidity, discoloration and changes in the physical properties of the excipient. The peroxide value can therefore be used to monitor the degree of oxidation of an excipient and to determine its shelf life. The latter can then be extrapolated for the finished medicinal product.

To detect the peroxides, a sample is mixed with a potassium iodide solution, which produces iodine. The amount of converted iodine is calculated by means of titration using a spectrophotometer.

What is the highest permitted peroxide value?

The acceptable level of peroxide for a particular pharmaceutical excipient depends on a variety of factors, including the intended use, the specific needs of the drug product formulation and regulatory requirements. In general, a peroxide level below 10 meq/kg is considered acceptable for most pharmaceutical excipients, but may be lower for excipients used in sensitive medicinal products or intended for long-term storage.

Particularly medicinal substances that are sensitive to oxidation require the lowest possible peroxide value. It therefore has a direct influence on the stability and shelf life of a drug and is a benchmark for its quality. An extended shelf life and service life is also an important contribution to the cost efficiency of a product. A corresponding evaluation of the peroxide value in the course of formulation development can therefore have a positive influence on the time to market.

At IOI Oleo GmbH, the quality of the raw materials is paramount and the suppliers must adhere to strict qualification protocols. The DeNovo synthesis of all products under cGMP ensures that our products not only meet the quality requirements but even exceed them.

You can find out more about our quality standards in our “Quality and Regulatory” brochure. For all other questions, we are at your disposal at any time.