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Stability and drug release testing

As one of the SYNLAB pharma core services we provide stability studies in accordance with ICH Q1A(R2), including consultancy, planning, storage and analysis. SYNLAB pharma supports all stages of successful drug product registration:

  • Long-term, intermediate and accelerated stability
  • On-going and follow-up stability studies
  • Stress testing (including photo-stability testing)
  • Compatibility studies

Following temperatures are available at SYNLAB pharma:

  • -20°C
  • 2-8°C
  • 25°C / 60% RH (Chamber and freezer)
  • 30°C / 65% RH (Chamber and freezer)
  • 40°C / 75% RH (Chamber and freezer)

Specific customer needs concerning stock take are available on request.
Please also visit our sections Analytical Techniques and Storage Capabilities.

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Fellbach wird neuer Laborstandort
Nach zweijähriger Planungs- und Umbauphase entstand in Fellbach das neue Labor der SYNLAB Analytics & Services Germany GmbH.
Aug 10, 2018 Continue
Determination of the Impurity N-Nitroso dimethyl amine (NDMA) in Drug Substances with GC-MS

Due to contamination of a drug substance with the potential mutagenic substance N-Nitroso dimethyl amine (NDMA) a massive recall campaign was initiated for the related drug products. SYNLAB Pharma offers a GC-MS test for testing the absence of NDMA in drug substances and drug products.

Please contact our experts.

Jul 13, 2018 | Pharma Continue
New Services in Regulatory Compliance for Biologics

With immediate effect, SYNLAB Pharma provides a broad support in the field of Regulatory Compliance of Biologics development. With this new services we support specifically start-ups, small to medium sized biotech companies, which require professional consultancy and project execution in regulatory project design.

For further questions, please contact:

Jun 18, 2018 | Pharma Continue
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