Nelson Labs Europe provides services in every step of the life cycle of a drug product, small or large molecules:
- Stability testing during drug development
- Formal stability testing:
- Forced degradation studies
- Photo stability testing according to ICH guidelines
- Identification and synthesis of unknown degradation products and impurities
- Development and validation of stability-indicating methods
- Stability analyses
- Registration batches
- Ongoing stability testing
Nelson Labs Europe has gained experience in analyzing stability samples for more than 10 years for evaluation of the leached impurities and interaction with drug matrices. Now, Nelson Labs Europe offers the capability to combine core stability testing services with world-class extractables and leachables. Both stability and leachable programs are run in parallel in order to differentiate drug substance degradation products from impurities, respectively, and expedite your projects.
Additionally, we offer identification of unknowns and synthesis thereof, for quantitative monitoring for subsequent stability and/or leachable projects.
Nelson Labs Europe has chosen to work with stability chambers, mainly for flexibility in conditions and storage capacity. Chambers are fully GMP qualified and continuously monitored with an alarm system. Backup chambers are available and emergency electric power generators are in place to ensure continuity of the aging process.
DS: Drug Substance (Active Pharmaceutical Ingredient)
DP: Drug Product (as marketed)
Other storage conditions are available on request.
|Standard conditions||25±2 °C/60±5 %RH|
|30±2 °C/65±5 %RH|
|40±2 °C/75±5 %RH|
|DS/DP intended for storage in refrigerator||5±3 °C|
|25±2 °C/60±5 %RH|
|DS intended for storage in freezer||-20±5 °C|
|DP in semi-permeable containers||25±2 °C/40±5 %RH|
|30±2 °C/35±5 %RH|
|30±2 °C/65±5 %RH|
|40±2 °C/25±5 %RH|
|Ultralow temperature for biotech products||-80 °C|
If you have additional questions about Pharmaceutical Stability Studies testing services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.