Analytical Testing Services
We understand managing your supply chain is a challenge. You need a CDMO that has the instrumentation, capacity, and experience to analyze your finished product. Take advantage of our in-house GMP analytical testing services to accelerate turnaround and expedite your important timelines.
Analytical Method Development
LSNE provides full analytical and assay method development services. We have a complete array of analytical equipment and the tools to efficiently meet your parenteral development needs that will provide you with timely, reliable, and consistent results.
Method Transfer, Qualification & Validation
Existing validated methods can be transferred to us or we can develop a product-specific method in-house. Our phase appropriate ICH validation approach for all of our analytical methods supports development, in‑process, release, and stability testing.
Testing Services
Our full-service laboratories are equipped with a variety of instrumentation to meet your testing needs. LSNE continues to evaluate and expand our testing capabilities to support our clients growing needs.
Analytical & Microbiological Testing Capabilities
- Gas Chromatography (Direct Injection & Headspace)
- Liquid Chromatography – UPLC and HPLC
- FTIR
- UV/Vis
- Residual Moisture by Karl Fischer
- Particle Sizing
- Oxygen Headspace Analysis
- SDS-Page
- Appearance
- pH
- Osmolality
- Density
- Reconstitution Time
- Subvisible Particulate Matter (USP <788>)
- Extractable Volume (gravimetric)
- Elemental Impurities
- Anti-microbial Effectiveness Test (AET)
- Preservative Efficacy Test (PET)
- Bioburden
- Endotoxin
- Sterility
- Container Closure Integrity
ICH Stability Studies
We can help you build a stability program around the specific requirements of your product, and can manage every aspect of your ICH stability program:
- Protocol development utilizing ICH stability guidelines
- All ICH conditions available in validated stability chambers
- Time point management and sampling by dedicated stability team
- Time point testing and data reporting with quality oversight
- Interim and final reports
ICH Q1B Photostability
We have the capability to perform non-GMP and cGMP photostability studies for drug substance and finished product.
- Photostability protocol development utilizing ICH Q1B stability guidelines
- Storing products in validated photostability chambers at the recommended light intensity
- Time point management, time point testing, and data reporting with quality oversight
- Final report
Connect with an Expert
By using our in-house cGMP analytical testing services, we can accelerate turnaround times, so you can expedite important timelines.
Trust that we can help you with your wide-ranging analytical needs.