Stability Storage Overview
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 ICH for new drug substances and products and were published as part of the Q1A Guidelines.
Reach-in chambers are also available for alternative temperature storage conditions ranging from -80°C to 60°C, and from dry heat to 75% RH. Freeze/thaw studies can also be performed using any variation of freeze and thaw conditions. All storage conditions are fully validated and monitored 24/7 by temperature and humidity probes connected to an independent data acquisition system. Thermocouples, chart recorders, and thermometers are on a routine calibration and maintenance program. All of the chambers are supported by a backup generator in the event of a power failure.
Photostability chambers are also available for ICH guideline requirements with CW and/or UV options.
In the event that you require a different configuration for temperature, humidity, or light exposure, Nucro-Technics can custom design and build a solution to fit your needs.
Nucro-Technics has the expertise to develop stability testing 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. Testing can be performed within Nucro-Technics’ Analytical Chemistry, Microbiology, and Toxicology groups for a turn-key solution to meet FDA, Health Canada, and EMA regulatory requirements.
Stability samples are labelled with time and storage condition information. Reports may include individual test point results, summaries at specified time periods, or trending data at the study’s conclusion.