Stability Studies and Evaluation
Stability study of a pharmaceutical product is a matter of great concern, in order to study its safety and efficacy throughout its shelf life and it has become a prerequisite for the acceptance and approval of any drug product.
Pharmaffiliates caters its clients with
- R&D preliminary studies
- Quality control stability studies and release testing
- Comparator studies
- Photostability studies
All stability studies are performed in accordance with the ICH Q1A-Q1F guidelines. Stability indicating methods are developed at Pharmaffiliates Analytical Research Department and these methods are used while performing stability studies for several APIs and Drug products.
Our stability equipments like Stability ovens, walk-in Chambers, and analytical instruments are fully qualified in accordance with the standard operating procedures and all the laboratory instruments are computerized with 21CFR part 11 compliance.