To complete our integral service and in collaboration with Sincromed, we have a Stability Studies department that includes:

• Preliminary stability studies
• Stability studies according to ICH Q1A guideline
• On-going stability studies
• Forced degradation studies
• Photostability studies according to ICH Q1B guidelines
• Compatibility studies
• Sample storage service at controlled conditions

 

STORAGE CONDITIONS

Study period	Conditions
Long term zone II	25 ± 2 ºC / 60% ± 5% H.R.
Long term zone IVb	30 ± 2 ºC / 65% ± 5% H.R.
Intermediate conditions	30 ± 2 ºC / 75% ± 5% H.R.
Accelerated conditions	40 ± 2 ºC / 75% ± 5% H.R.
Other conditions	2 – 8 ºC