Stability Storage & Testing
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. All of our chambers are continuously monitored through a computer database system and are on full generator back-up.
Core testing and analysis expertise covers: R&D preliminary studies, finished product, API's, high throughput QC stability & release testing, comparator studies and additional capabilities for photo stability studies.
All stability studies are performed in accordance with the ICH Q1A-Q1F. For these Stability Indicating Methods are developed and made use of while performing Stability studies for the APIs and Drug Products.
All stability ovens, Walk in Chambers and Analytical instruments are fully qualified. Majority of the analytical instruments are 21CFR part 11 compliant.
- Compliance with Global Quality Standards.
- Commitment to Quality and Timely deliverance.
- Qualified and Competitive team.
- Quality at a Reasonable cost.
- Ready to face audits by worldwide Regulatory authorities.
- First Indian company to perform audits for European customers in accordance with EMEA requirements.
- Our 2500 Impurities synthesized
- Our 300 Methods Developed & validated
- State of the Art Facilities
- Working for European and US customers