Stability Studies

Pharma

Stability Studies

We provide stability testing on Drug products specially during development and post surveillance study. Our stability operations have extensive storage capacity for all ICH conditions as well as custom storage conditions. Our stability chambers are continuously monitored through a computer database system and are on generator back-up.

Core testing and analysis expertise

R&D preliminary studies, finished product, API’s, high throughput QC stability and release testing, comparator studies and additional capabilities for photo stability studies.

All stability studies are performed in accordance with the ICH Q1A-Q1F guidelines. We develop stability Indicating Methods and made use of those while performing stability studies for APIs and Drug products.

Stability ovens, walk -in Chambers and analytical instruments are fully qualified. Computerized Laboratory instruments are 21CFR part 11 compliant.

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