STABILITY STUDIES

IDRI’s stability programs are designed and managed per ICH compliant protocols. The study scopes can cover long-term and accelerated stability studies.

We work with clients to execute their protocol, design a protocol  or  mutually design the right stability study to accommodate any special needs associated with a client’s drug product. The protocol will specify frequency of testing and storage conditions (temperatures, position); the appropriate stability-indicating methods; and degradation products that may be stability limiting.

Stability programs at IDRI encompass:

  • Accelerated stability
  • Long term stability
  • ICH compliance
  • Method transfer and/or development as needed
  • Storage conditions
  •  ≤-65°C
  • -25 to -10°C
  • 2 to 8°C
  • 22°C
  • 35°C
  • 37°C