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:
- -25 to -10°C
- 2 to 8°C