The containers and systems of administration of pharmaceutical and biopharmaceutical products are intended to protect them from environmental contaminants, but at the same time they can be a source of contamination in themselves. Similarly, polymeric materials used in pharmaceutical manufacturing processes or plastic components used in medical devices can be a risk due to the possible transfer of compounds and additives to the product.

Controlled extraction studies allow the identification and quantification of extractable impurities that could migrate from the polymeric material to the pharmaceutical product under stress conditions.Then, the toxicological risk analysis allows to define the real presence of each extractable in the maximum dose of the product.

Finally, based on the results of the toxicological risk analysis and always taking into account the type of product, leachable studies can be carried out that will allow the evaluation of the presence of leachable impurities in the finished product ensuring the quality of the product and its safety for the patient.

 

What Netpharmalab offers to you…

In collaboration with DALIA GLOBAL SERVICES we offer a complete service for the toxicological evaluation of extractables and leachables.

The combination of our specialists in ultrasensitive analytical techniques with the huge experience of toxicologists of DALIA GLOBAL SERVICES, allow us to offer an agile, professional and quality service.