2. TOXICOLOGICAL CHARACTERIZATION OF EXTRACTABLE AND LEACHABLE IMPURITIES
Controlled extraction studies allow the identification and quantification of extractable impurities, in other words, impurities derived from the packaging material or polymeric material used in the manufacturing processes of the medicinal product and which could migrate from the material to the pharmaceutical product under severe conditions of use.
The toxicological risk analysis based on the results of the extraction study will make it possible to define the actual presence of each extractable impurity at the maximum dose of the medicinal product. This risk analysis shall be carried out using specific toxicological values for each extractable impurity and always considering the route of administration of the medicinal product. Finally, on the basis of the result of the toxicological risk analysis, the need to carry out simulation studies or leachables studies shall be defined. These studies allow to confirm or rule out the presence or absence of extractable impurities under normal conditions of use.
- Estimation of amount of extractable in maximum daily dose of product.
- Calculation of toxicological thresholds for each extractable
- Risk analysis
According to the risk obtained: simulation studies on the polymer material or leachable studies on the product shall be proposed.
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- Calculation of toxicological thresholds for each extractable
- Risk análisis
- Designing additional studies, if needed (simulation studies on the polymer material or Leachable studies on the product)