Analytical Services
Source: August Bioservices
Our team’s expertise and on-site laboratories are equipped with state-of-the-art instruments.
Comprehensive analytical and microbiological development, testing, and characterization services
We support CMC submission readiness with on-site full raw material and USP <1> injectable testing, as well as advanced product characterization capabilities. Our goal is to ensure an efficient and simplified process for our customers that eases the burden of managing multiple vendors and accelerates timelines.
Analytical chemistry
- Full USP and EP raw material testing
- Drug substance testing
- Full USP <1> release testing for injectables
- Analytical method development and validation
Advanced product characterization
- Elemental impurity testing
- Particle size distribution analysis
- Residual solvent testing
- Extractables and leachables
- Structural elucidation
- Photostability and thermocycling
- Nitrosamines
Microbiology testing
- Endotoxin testing
- Bioburden testing
- Antimicrobial effectiveness testing
- Sterility testing
- Container closure integrity testing
- Environmental monitoring
ICH stability zone I-IV study design and execution
- All ICH conditions for both impermeable and semi-permeable containers
- In-use stability, photostability, and compatibility studies
- Thermal cycling, freeze-thaw, and distribution studies
- Clinical, registration, and commercial stability
- Statistical modeling and shelf-life assignment