We have a dedicated Stability and Analysis group providing services for all stages of drug development, from early research & development to commercial/post approval studies. These services are provided in full compliance with ICH, Health Canada and FDA guidelines. Our Stability department is integrated within the laboratory complex and provides the following services:
- 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
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Storage Storage Conditions
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Diteba provides a full range of ICH compliant stability storage conditions, including:
- 25°C/60% RH
- 30°C/65% RH
- 40°C/75% RH
- 5°C
- -20°C
- -80°C
- Photostability (UV and Daylight)
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