Stabilitätsuntersuchungen (ICH)

 

Klimabedingungen

  • 5oC
  • 25oC / 60% RH
  • 30oC / 60% RH
  • 30oC / 65% RH
  • 40oC / 75% R H
  • Other storage conditions on request
  • Photostability


Stress Testing

  • High temperature
  • Acid hydrolysis
  • Base hydrolysis
  • Oxidative analysis tests
  • Photolamp
  • Stress conditions, defined by client
  • Exploratory and definitive studies


Experience

  • Stability studies for drug registration
  • Follow up stability studies
  • Container studies
  • Compatibility studies


Quality Control

  • Labwatch system with continous temperature  and humidity monitoring
  • E-mail and SMS alarm system overnight and during weekends
  • Backup generator
  • Redundant operating systems
  • Frequent calibration