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.
According to the ICH Guideline Q1AR2, stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances.
NEWTRONIC offers a range of test chambers to meet these regulatory requirements as well as stability testing requirements for other industry segments of Cosmetic, Food & Beverages, etc.
We offer a centralized solution across all ICH conditions of real-time, intermediate, accelerated & semi-permeable study conditions along with a state-of-the-art 21 CFR Part 11 ready software that provide tools for viewing, trending, alarm management, audit trails, MKT & many other such features.
|Temperature Range||20°C to 60°C|
|Temperature Accuracy||± 0.2°C|
|Temperature Uniformity||± 1°C|
|Humidity Range||40% RH to 95% RH|
|Humidity Accuracy||± 2% RH|
|Humidity Uniformity||± 3% RH|