The Diapharm Analytics service laboratory assists manufacturers from initial pharmaceutical development and the stability testing of bulk or final products through to in-use stability studies, stability monitoring of post-marketing batches (on-going stability testing) and testing in connection with variations.
Stability testing is required in order to determine and validate the chemical and physical shelf-life under specific storage conditions (humidity, temperature). In the run-up to clinical studies, stability testing is used to ensure that the shelf life of a study drug is sufficient to last for the duration of the study. Long-term studies involving the finished product are required for marketing authorisation. Following this, manufacturers are legally obliged to undertake on-going stability studies on a regular basis, so that they are able to prove that the medicinal product in question can be used safely over the entire period of its shelf life.