At every state of your drug development program, Exova supports you with advanced pharmaceutical stability storage and testing services.
The conditions under which drug products are manufactured, transported and stored can influence their efficacy. Stability studies help to estimate the impact of transportation and storage on drug and medical device performance by stressing materials under exaggerated environmental conditions. Appropriate temperature, humidity, and light guarantee that drugs are delivered to patients without loss of therapeutic properties.
Stability studies enable identification of any potential chemical or physical changes that could potentially impact product safety and quality. The data obtained from these studies allow optimal transportation and storage conditions to be established and verify product shelf-life.
Exova’s stability storage and testing services include:
- Stability protocol preparation, coordination, and execution by a highly experienced team familiar with a range of dosage forms, devices, and delivery systems
- Development and validation of stability-indicating assays, including forced degradation studies
- Accelerated test programs in support of prototype evaluation and process development
- Complete chemical and physical analytical testing capabilities supported by senior scientific staff for timely investigation and resolution of out of specification results.
Our stability programs are strictly controlled using 21CFR, part 11 compliant project management software. With chambers monitored, fully validated and alarmed, whether your project is a small one-off study or a major program we can provide you with a low-risk, high-quality stability study.
International Conference on Harmonization guidelines (ICH) conditions offered include:
- -20°C (± 5°C)
- 5°C (± 3°C)
- 25°C/40%RH, 25°C/ 60%RH (± 2°C/±5%RH)
- 30°C/35%RH, 30°C/ 65% RH, 30°C/75%RH (± 2°C/±5%RH)
- 40°C/ 75%RH (± 2°C/±5%RH)
Exova’s stability team provides high-quality data in support of all stages of drug and device development, from early research through full finished product studies that adhere to ICH guidelines.