Analytical method qualification and validation by scientist

Analytical Testing

LSNE performs rigorous analytical testing to support in-process, release, and ICH stability testing. To further support your testing needs, we can perform analytical method development, support efficient method transfers and adhere to phase appropriate method validation.

Commitment to Quality

Whether we are supporting your manufacturing testing needs or providing standalone testing services, our Analytical Chemists work closely with Project Management to understand your critical timelines and provide personalized one-on-one attention. As a CDMO dedicated to quality, we work closely with our clients to provide accurate, clear and concise documentation, and we ensure that our quality systems are driven by continuous improvement. We are committed to deliver solutions that meet the most stringent regulatory compliance standards and support all of our client’s analytical testing demands.

2 scientists

Analytical Testing Services

We have three full-service laboratories equipped with a variety of instrumentation to meet your analytical testing needs including:

  • Gas Chromatography – Standard Injection and Headspace Analysis
  • Liquid Chromatography – UPLC and HPLC
  • FTIR
  • UV/Vis
  • Residual Moisture by Karl Fischer
  • Particle Sizing
  • Oxygen Headspace Analysis
  • Subvisible Particulate Matter (USP <788>)
  • SDS-PAGE
  • Appearance
  • pH
  • Osmolality
  • Density
  • Reconstitution Time
  • Extractable Volume (gravimetric)

Microbiological Testing Services

Our microbiologists can limit the amount of API or BDS required to qualify your microbiological tests.

  • Bioburden
  • Endotoxin
  • Sterility
  • Container Closure Integrity
  • Anti-microbial Effectiveness Test (AET)
  • Preservative Efficacy Test (PET)
Commercial Manufacturing Services