STABILITY TESTING SERVICES
NUCRO-TECHNICS offers a wide range of stability storage conditions, including the three primary conditions most commonly used and specified by the International Conference on Harmonization (ICH): 25°C/60% RH, 30°C/65% RH, and 40°C/75% RH. These guidelines were developed by the Expert Working Group (Quality) of the ICH for new drug substances and products and were published in final form in the Federal Register on September 22, 1994.
Several reach-in chambers are also available for alternative temperature storage conditions ranging from -20°C to 55°C, and from dry heat to 75% RH. Multiple light exposure configurations are available as well. In the event that you require an uncommon configuration, Nucro-Technics can custom design and build a solution for your needs. All storage conditions are fully validated and monitored 24/7 by temperature and humidity probes. Thermocouples, chart recorders, and thermometers are on a routine calibration and maintenance program. All of our chambers are supported by a backup generator in the event of a power failure.
NUCRO-TECHNICS has the expertise to develop protocols that will generate the necessary data to answer questions which arise during development, clinical testing, and post-marketing of products. We have a highly capable method development group for the development and validation of stability indicating assays. The protocol development process conforms to cGMP requirements, and validation studies are suitable for regulatory submission internationally.
Stability samples are labelled with time and storage condition information. Reports may include individual test point results, summaries at specified time periods, or cumulative data at the study's conclusion.