To guide your formulation development efforts and identify risks, AMRI offers customized stability testing that includes developmental and packaging studies, stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.
Qualified stability chambers are available at standard ICH conditions of:
- -20 °C
- 5 °C
- 25 °C/60% RH
- 30 °C/65% RH
- 40 °C/75% RH
- -70 °C
We also offer photostability studies and can coordinate with qualified third-party storage sites.
Our experts offer testing on a variety of container choices for aseptic filling, including:
- Prefilled syringes: traditionally filled, bubble-free filled
- Vials: liquid filled, lyophilized
- Glass, plastic and silicone-free material
We also provide in-process and release testing to evaluate:
- Strength
- Identification
- Purity
- Safety
- Potency
- Quality