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ORAL PRESENTATION / SÖZLÜ SUNUM

The Importance of Stability-Indicating Analytical Methods in the Quality Control of
Veterinary Medicinal Products, and Recommendations for Planning Forced Degradation

Studies

1
Onur DEMİR 1,* Erdim Ozan ÇAKIR

1 Republic of Türkiye Ministry of Agriculture and Forestry, Pendik Veterinary Control

Institute, Pharmaceutical Quality Control Laboratory, Istanbul, TÜRKIYE

*Correspound Author: demir.onur@tarimorman.gov.tr

Veterinary medicinal products are indispensable for animal health and are also

particularly important for the One Health approach. Guaranteeing the quality, safety and
efficacy of veterinary medicinal products requires the stability of their active pharmaceutical

ingredients. Problems related to the stability of the active ingredient can lead to reduced
efficacy, toxicity and the formation of residues in food and the environment. Therefore, when

developing veterinary medicinal products, validated analytical methods with stability
indicating should be used to investigate degradation pathways, products and levels.

Forced degradation studies test the active ingredient and finished product under
conditions that are more severe than those of accelerated stability to assess worst-case

scenarios. These studies are necessary to demonstrate the specificity of analytical methods
and help elucidate the structure of degradation products. Based on the information obtained

from these studies, product formulation is developed, product spescifications are

established, storage and distribution requirements are determined. Stability-indicating
analytical methods, which are developed by designing and evaluating forced degradation

conditions, are invaluable in the development of high-quality products. The aim of this
presentation is to share current information on the importance of stability-indicating

analytical methods in the quality control of veterinary medicinal products, as well as
strategies for planning forced degradation studies.

Keywords: Forced degradation, Stability-indicating analytical method, Quality control,
Veterinary medicinal products.

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