Intermediate Testing
Price On RequestDuring the entire test, the deviation in temperature is stipulated at 2 C and the deviation in relative humidity is stipulated at t5%RH. According to the ICH guideline , stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances and pharmaceuticals. In cooperation with the pharmaceutical industry, we have developed a specific range of test cabinets and test chambers to meet these requirements. Stability tests are an important step in the development of new drugs and pharmaceutical substances and an indispensable element in the licensing process defined by federal regulating authorities. However, these tests are just as important for safeguarding the quality of the product within the framework of quality assurance. Together with committees from the pharmaceutical industry, experts from the licensing authorities (such as the FDA) have developed the ICH guidelines for the harmonization of stability tests. These guidelines define standardized storage and batch evaluation as well as the time sequence of the required analytic tests.