Stability Testing and Storage

RSSL Pharma offers a complete solution for undertaking stability testing of a variety of drug products including controlled substances as wall as offering storage space.

Our in-house stability testing storage facility is run to the recommended ICH guidelines and includes the following conditions:

• 25ºC/60% RH
• 30ºC/65% RH
• 30ºC/75% RH
• 40ºC/75% RH
• 5ºC
• -20ºC Freezer
• Photostability
• Other stress conditions as appropriate to Client's requirements

Each stability chamber is continuously monitored by a computerised system which is 21 CFR compliant and staff are on 24 hour callout should a stability chamber fall outside the set point ranges.

Our experienced staff provide advice and support on stability protocol preparation, development of stability indication methods and method validation to GMP.

RSSL Pharma supports long term and accelerated stability testing studies and will accommodate testing to Client supplier methodology.