Stability Storage And Testing Services
Ensuring product quality is one of Boston Analytical's main goals. That is why, since our inception in 1987, we've committed to providing a comprehensive line of stability testing and storage services that meet ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and FDA guidelines for drug development and follow-up stability studies.
Stability testing provides evidence on how the quality of an active substance, or other pharmaceutical product, will perform over time. A product's stability can be influenced by many different environmental factors such as temperature, humidity, light, or the chemical or physical properties of the pharmaceutical excipients.
The stability of a product may also be influenced by the container that it is in. As such, at Boston Analytical, we perform tests that will provide information as to whether the packaging is reactive, additive, or absorptive. This ensures that the identity, strength, quality and purity of the drug product are not affected.
Our Stability Testing Services Include:
We offer a comprehensive line of stability testing capabilities to meet ICH and FDA guidelines for drug development and follow-up stability studies, including:
- Stability Testing during all stages of Drug Development:
- Formulation Development & Optimization
- Clinical Phase Studies
- Commercial Release
- Annual Stability Studies
- Blind Comparator Studies
- Photostability Testing
- Photodegradation Studies
- Freeze Thaw Studies
- Thermal Cycling Testing
- On-site Storage of Product Samples
ICH-Compliant Stability Storage Chambers with Flexible Testing Options
Our stability samples are housed in ICH compliant storage chambers. All chambers and rooms are mapped, monitored for temperature and humidity, alarmed, and backed up with emergency power to ensure accurate results. We have reserve ICH-compliant stability chambers available to support your specific testing needs should you require alternative conditions for a specific product.
At Boston Analytical, we're committed to quality client service and accurate data; that begins with our Stability Testing and Storage Services. Contact us today to begin your Stability Testing with Boston Analytical.