Do you require stability testing for the registration of your new drug substance or pharmaceutical product? Eurofins Sinensis can be your complete outsourcing partner to register your product for various international markets. Our WHO prequalified laboratories in Leiden, the Netherlands, are fully equipped for stability testing compliant to European, British, US and Japanese Pharmacopoeia.
Standard ICH compliant stability testing
One of our core businesses is to determine the quality of your pharmaceutical substance. Our laboratories are well equipped to perform all necessary standard stability studies like:
- ICH climate conditions (chambers and cabinets)
- Extractable and Leachable testing
- Forced degradation (including Photo stability testing)
- Holding time studies
- In-use stability testing
- Freeze-thaw stability testing
Tailor-made stability testing solutions
If your pharmaceutical products require additional stability testing beyond the scope of the ICH guidelines, Eurofins Sinensis is your ideal partner. In close collaboration, together we will determine your specific requirements and make sure that the product meets the highest international quality standards.
If you require advice or more information on standard or tailor made stability studies, please contact us to discuss your specific needs. If you are a step ahead and wish to request a quotation, fill in this form and explain your needs if possible. We will contact you as soon as possible.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom services. Whenever necessary, additional services like pure culturing and/or testing of more, other genes can be provided. Please contact us if you want to discuss your needs.