STABIILSUSUURINGUD
STABIILSUSUURINGUD
PEAMISED STABIILSUSTEENUSED
Ongoing commercial stability can be a costly and challenging part of doing business – particularly if you’re using a third-party contract manufacturer. At The J. Molner Company, we have pioneered an economical ICH commercial drug stability service that gives you operational flexibility with Nordic quality.
Our Nordic Stability Service provides your team:
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Full ICH Stability Testing Services: in controlled temperature and humidity conditions according to ICH guidelines (clinical zones I to IV)
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Real-Time and Long Term Stability
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Accelerated Stability
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Forced Degradation Studies
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Stress Stability Studies
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R&D Stability Testing
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In-Use Stability Studies: stability studies to determine periods of use for multidose or reconstituted drugs
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Photostability testing by ICH Q1B
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Ambient/Controlled Room Temperature: 15°C to 25°C
Refrigerator: 2°C to 8°C -
Deep-freeze: below -15°C
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Accelerated Stability Testing: 40°C ± 2°C/ 75% RH ± 5% RH
Intermediate: 30°C ± 2°C/ 65% RH ± 5% RH
Long-Term Stability: 25°C ± 2°C/ 60% RH ± 5% RH -
Stress Stability Testing: 50°C
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Cycling Chamber Stability Studies: Freeze-Thaw and extreme temperature stability studies