Stability Testing

Nelson Labs Europe provides services in every step of the life cycle of a drug product, small or large molecules:

1. Stability testing during drug development

2. 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

3. On-going 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 of being able 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 between 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. 

 

Storage Services

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. 

 

Available Storage conditions

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

Contact:


Nelson Labs Europe
Romeinsestraat 12
B-3001 Leuven
Belgium
+32.16.400484
InfoEurope@nelsonlabs.com

Nelson Labs Europe | Pharma Stability Testing