Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.
We understand the importance of high quality and timely analytical support to the success of a drug development program. Our approach is to optimize for success by maintaining a high ratio of analytical support staff to chemists and engineers on every project. Ash Stevens has over 50 years of experience providing broad analytical support for a wide-range of chemistries, developing and validating analytical methods using state-of-the-art technologies and instrumentation.
Analytical Capabilities Include:
- Methods development
- Methods validation
- Specification development / material testing
- Structural analysis
- Impurity isolation and identification (including GTIs)
- Product characterization and purity assessment (HPLC, GC, GC/MS, LC/MS, Heavy Metals, Karl Fischer)
- ICH stability studies (storage and testing)
- Reference standard qualification and maintenance
- API solids characterization
- Cleaning method development and validation
- Test and release of starting materials, intermediates and final products
- Impurity profiling