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STAND ALONE SERVICES

ANALYTICAL DEVELOPMENT» STABILITY STUDIES»

 

Rubicon offers instant resource deployment for stand-alone analytical services. We have a team of chemists and senior scientists, product experts, quality testing services and a robust project management and communication systems to ensure highest quality analytical services.

Rubicon’s analytical services department has more than 100 scientists across the two locations and services include:

  • API Characterization
  • Analytical Method Development
  • Analytical Method Validation
  • Microbiological Testing

Rubicon has more than 8 years of experience in providing high quality support for pharmaceutical stability projects. We strictly adhere to ICH guideline to perform stability studies. Rubicon has been certified by the German Health Authority “Freie und Hansestadt Hamburg” (Hamburg De – BSG) for stability testing and analytical services. We support stability studies for early R & D, full ICH studies, phase III/NDA supporting studies, commercial /post approval studies, stability studies for drug registration, follow up stability studies, container/Compatibility studies.

Stability testing services include,

  • Long-term stability
  • Accelerated stability
  • Stress testing (forced degradation)
  • Photostability

Included storage stations are, 250C / 60 % RH, 300C / 65 % RH, 300C / 75 % RH, 50C ± 3°C, 400C / 75 % RH – 200C