Acid value as a central, objective quality factor for lipid excipients

16. January 2023

The selection and qualification of a manufacturer of excipients and active ingredients is one of the main tasks of quality management, which aims, among other things, to ensure the manufacture of effective and safe pharmaceuticals. In this context, monographs serve as a guide to evaluate raw materials regarding their physico-chemical properties and also help to compare different sources of the “supposedly” same raw material.

The parameter “acidvalue” is a requirement for lipid excipients in almost all materials. So why should special attention be paid to this seemingly trivial chemical parameter and the procedural competence of a manufacturer to reproduce low values?

In a narrower sense, this parameter quantifies the content of free (fatty) acid in the raw material, which is typically regarded as an undesirable impurity. Minimum levels are usually not specified, but the European Pharmacopoeia defines values of e.g. 0.2 – 6 mg KOH per gram of substance as upper parameter limits.

First of all, this acid value provides information about how much effort was invested during production to purify the excipient or active substance. However, certain contents are always permissible if the monograph limits are observed. A certain increase in this valuecan occur spontaneously over the course of the shelf life. It should be considered that free fatty acids are the result of natural processes in the material and can have catalytic effects. Elevated levels in fresh and stored material can be problematic, since free fatty acids tend to cause or catalyze a number of undesirable reactions with themselves, the other excepients and the active ingredients. The consequences may be a limited shelf life and effectiveness of the final drug product.

We, IOI Oleo GmbH, understand the low acid value of our products as one of the primary indicators of quality and stability for well-made lipids and as a contribution to stable and long-lasting pharmaceuticals. Our team will be happy to answer any further questions you may have regarding the objective assessment of the quality of lipid excipients and active ingredients.

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Robert Radsziwill

Robert is the Business Development Manager for Functional Excipients in the Pharma Division of IOI Oleo GmbH. Prior to this role he held technical and commercial roles focusing raw materials used in the pharmaceutical and medical device industry for 13 years. In each position he leveraged his diploma degree in Business Chemistry earned at Westfälische Wilhelms-University to drive interdisciplinary projects and work as interface between commercial and technical decision makers. Understanding technical, commercial and regulatory drivers from ideation to successful project-completion is key for him. In his free time he enjoys guitar heavy music as well as cooking for and with family and friends.