STABILITY & STORAGE

Data-driven certainty, by time-tested studies

STABILITY & STORAGE

Data-driven certainty, by time-tested studies

Stability Storage

Boston Analytical’s stability laboratory, located within our 30,000 square-foot facility, contains redundant, ICH-compliant stability chambers, maintained by on-site staff. We can help you understand how your product will react to being stored for extensive periods of time at determined temperatures.

Thermal Cycling Stability Testing

To determine the impact of temperature excursions on a product, Boston Analytical designs and performs freeze thaw testing with thermal cycling, to stress test pharmaceuticals. Our thermal cycling stability testing can provide you with information on how the shipment of your product at varying temperatures will affect its performance.

Photostability Testing & Photodegradation Studies

At Boston Analytical, a dedicated photostability chamber reveals what happens to your pharmaceutical product when exposed to ICH Q1B light conditions. With this data, you can have a greater understanding of how light exposure will change your product’s composition.

Clinical Registration & Annual Stability Studies

Boston Analytical has been a trusted vendor for annual stability studies for over 30 years, providing cGMP data and documentation appropriate for clinical registration. We can assist you with the information to be FDA compliant and to adjust to the nuances of your product and needs.

Blind Comparator Stability Studies

Boston Analytical is experienced in blind comparator stability studies and depending on what is needed will perform dissolution, appearance, identification, impurities, and assay tests. We can help you demonstrate the equivalence of your product or superiority to a marketed product.