The presence of extractables and leachables impurities in a pharmaceutical product may lead to a change in its composition and constitute a serious health risk due to its toxicological properties.
Regulatory agencies require that toxic substances in packaging materials do not migrate into the drugs during their shelf life to avoid changes in therapeutic action, organoleptic properties or stability.
At Azierta, we perform complete studies of extractable substances and develop methods to monitorize the presence of leachable impurities in the final product.
1. Evaluation of packaging and production materials
During the first stage, we review the materials used in packaging and production to predict their compatibility with the pharmaceutical product. We do this by performing several studies:
- Specifications of each material: Compliance with pharmacopoeia, types of material, additives used and physical-chemical properties.
- The material’s conditions of use during product manufacturing and storage: Temperature and pressure and sterilisation processes.
2. Extraction and simulation studies
In this stage, we perform extraction studies on the materials to assess their degradation in extreme conditions in order to anticipate any potential impurities that could migrate from the material to the product. This involves:
- Designing a specific study for each material
- Using high-resolution combined analytical techniques
3. Toxicological evaluation
In this phase of the process, we perform a toxicological evaluation of the impurities detected in order to define their toxicological profile and the risk involved for patients. This evaluation is carried out through:
- Literature reviews
- Data migration via Read Across.
- QSAR methods for predicting toxicological end points
4. Toxicological risk analysis
Based on the results obtained in the extraction studies and considering the inherent toxicology of each extractable, we assess the risk posed by exposure to the impurity.
This risk analysis often enables us to circumvent additional studies on the finished product, leading to time and cost savings for the customer.
5. Leachables study
Leachables studies allow us to identify any impurities derived from the materials that may be found in the pharmaceutical product under normal conditions of use.
This process may not be necessary depending on the results obtained in the prior toxicological risk analysis.
We have a specialised toxicological support department made up of a multi-disciplinary team of expert toxicologists accredited by AETOX, EUROTOX y ERT.
Extractables and leachables impurities analysis
Toxicological support composed of a multidisciplinary team of toxicologists and chemical experts accredited by AETOX, EUROTOX and ERT