Laboratory Testing Resources

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Stability Storage and Testing

We have a dedicated Stability and Analysis group providing services for all stages of drug development, from early research & development to commercial or post approval studies.  These services are provided in full compliance with International Conference on Harmonisation (ICH), Health Canada and U.S. FDA guidelines.  Our Stability department is integrated within the laboratory testing complex and provides the following services:

Stability Storage and Testing

  • Protocol Design

  • Long Term Stability Testing

  • Accelerated Stability Testing

  • Drug Substance Stability Testing

  • IND, NDA, ANDA Stability Testing

  • Commercial Product Stability Testing

  • Comparator Stability Testing

  • Formulation Evaluation Stability Testing

  • Forced Degradation Studies

  • Photostability and Temperature Cycling

Storage Storage Conditions

Diteba provides a full range of ICH compliant stability storage conditions, including:

  • 25°C/60% RH

    Storage Conditions

  • 30°C/65% RH

  • 40°C/75% RH

  • 5°C

  • -20°C

  • -80°C

  • Photostability (UV and Daylight)