The AGON laboratory has grown steadily over the years. We now offer a range of services for product analytics that originated during the development of methods for traditional medicinal products as part of post-marketing surveillance. You will be amazed by the sheer range of what we offer – from method development and validation to stability testing and routine analysis for final batch release. Our highly qualified team remains up-to-date by means of continuous education, offering you flexible and reliable support in securing your supply chains and your marketing authorisations.
Your product - our analytical contribution
AGON is more than happy to conduct release testing of your medicinal products for final batch release or quality control on your behalf.
The AGON laboratory has over 30 years of experience in the development of analytic methods that originated during post-marketing surveillance of traditional medicinal products. We will develop a validated method for your project, or update your current method to reflect the most up-to-date science and technology.
Our modern climate testing facilities are located in Leonberg, located 40 kilometres away from our site at Wendlingen. We store your stability samples and monitor test times, and ensure appropriate removal from storage and environmental conditions, so that you don't have to.
After we have successfully developed a method for you, or updated your existing test procedures, we are able to perform validation activities based on your specifications and in compliance with the ICH Guideline Validation of Analytical Procedures Q2 (R1), as well as our internal rules of procedure. After appropriate consultation, the results are documented in a validation report that is ready for submission, usually in English.
You can find out more about our equipment here
Stability testing in accordance with ICH
Zone I ("temperate" 21°C/45 % RH), Thermotec TCS 501/L climatic chamber
Zone II ("mediterranean/subtropical" 25°C/60 % RH), Thermotec climatic chamber
Zone IVa ("hot humid/tropical" 30°C/65 % RH), Thermotec TCS 1702 climatic chamber
Zone IVb ("hot/higher humidity" 30°C/75 % RH), Thermotec TCS 1701 climatic chamber
"Accelerated ambient" zone 40°C/75 % RH, Thermotec TCS 1702 climatic chamber
Cold storage (2-8°C), BioPlus ER 930 and BioCompact II RR 410 medicine refrigerators
Photostability tests, Thermotec TCS 501/L climatic chamber
Special tests are available upon request