Stability Studies

October 6, 2014

Pharmaceutical stability studies are provided for all stages of drug development, from early stress studies to development of stability indicating assays, through clinical and finished product programs. Our team is fully conversant with ICH Q1A (R2) guidelines for new drug substances and food and nutraceuticals.

 

 

On-site storage stability facilities are located at our  Laval facility. 

 

Storage Stability Conditions 

 

 

  • 25ºC / 60% RH

  • 30ºC / 60% RH, 30ºC / 65% RH and 30ºC / 70% RH

  • 40ºC / 75% RH

  • 50ºC / 75% RH

  • 2-8ºC, -20ºC, -40ºC and -80ºC

  • Photostability (ICH Options 1 & 2)

  • Specialized conditions

 

 

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