ICH Stability Testing for Non-Sterile Products

At PCI, we pride ourselves on our comprehensive in-house stability testing services to support manufacturing services on behalf of our global clients, delivering safe and effective medicines to patients.

ICH testing guidelines are globally recognized and widely adopted standards for the development, registration, and post-approval of pharmaceutical products. These guidelines provide recommendations on various aspects of pharmaceutical development, including testing procedures and acceptance criteria.

Stability testing is performed to assess the shelf life and storage conditions of pharmaceutical products and involves subjecting the products to various environmental conditions, such as temperature and humidity, over a specified period. Stability testing helps determine the degradation rate of APIs and other ingredients, assess the product’s physical and chemical stability, and establish appropriate storage recommendations to ensure that the product remains effective and safe throughout its intended shelf life.

Our dedicated team of specialists will be happy to discuss any of our ICH Stability Testing Services with you. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com