Nelson Labs offers comprehensive stability services to support active pharmaceutical ingredients/drug substance (API/DS) and drug product (DP), including the following:
- Stability, storage, and testing
- Formal stability testing, including the following:
- Photostability testing according to ICH guidelines
- Identification of unknown degradation products and impurities
- Development and validation of stability-indicating analytical methods
- Stability studies in support of clinical development
- Registration batch stability studies
- Stability studies supporting extractables and leachables (E&L) evaluations, particularly for assessing leached impurities
Storage Services
Nelson Labs provides qualified stability storage in North America and Europe (Leuven, Belgium), including
- ICH-compliant, continuously monitored storage chambers
- Integrated alarm systems
- Backup chambers to prevent data loss
- Emergency power generators to ensure uninterrupted stability aging conditions
Details about storage conditions are provided in the table below. 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 | |
| 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 |
Note: Semi-permeable conditions are subcontracted to qualified partners in North America.
Testing Locations
- Salt Lake City, UT, USA
- Itasca, IL, USA
- Leuven, Belgium
To learn more about our locations and their certifications, click here.
Contact Us
If you have additional questions about pharmaceutical stability studies or would like to consult with our experts, just send us a request or call us at +1 (801) 290-7500.
