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. Whether your product is liquid or lyophilized we have testing capabilities appropriate to support clinical or commercial batches as well as for ICH stability studies. 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 substances and finished products.
- 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.