NORDIC STABILITY SERVICES

NORDIC Stability Services

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:

 

  • Full ICH Stability Testing Services: in controlled temperature and humidity conditions according to ICH guidelines (clinical zones I to IV)

  • Real-Time and Long Term Stability

  • Accelerated Stability

  • Forced Degradation Studies

  • Stress Stability Studies

  • R&D Stability Testing

  • In-Use Stability Studies: stability studies to determine periods of use for multidose or reconstituted drugs

Contact us today to see how the J. Molner Company can help you today with stability services - providing you Nordic quality while saving you on study costs.

COVID-19 CAPACITY

KEY ANALYTICAL SERVICES

  • Photostability testing by ICH Q1B

  • Ambient/Controlled Room Temperature: 15°C to 25°C
    Refrigerator: 2°C to 8°C

  • Deep-freeze: below -15°C

  • 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

  • Cycling Chamber Stability Studies: Freeze-Thaw and extreme temperature stability studies