Our laboratorium has over 30 years of expertise in different fields such as comprehensive method development, stability studies accoding to all guideline, and release testing.
METHOD DEVELOPMENT
The process of method development is research focused on the discovery of a suitable set of conditions for the analysis of your sample. Our laboratorium is uniquely qualified to aid you in this process. We have both the analytical knowledge as well as our own complete line of LC products. The discovery and application of these products has provided us with a depth of knowledge few others possess in separations.
- ICH Guidelines
- Precision
- Linearity
- Accuracy/Recovery
- Specificity
- Limit of Detection
- Limit of Quantitation
- Forced Degradation
- Peak Purity
- Peak Identification
- Ruggedness/Robustness
STABILITY STUDIES
Assistance can be provided with the design of stability protocols and methods. JLE products can store the samples on site and maintain the calendar pull dates. Additional chambers for accelerated and real-time conditions are added to meet customer demands. For clients who generate their own stability samples, we offer analyses using the provided methods. Turnaround time is set by the customer, typically 1-2 weeks. We realize that there is rarely a “routine” analysis involved in stability work; our scientific depth and corporate philosophy enable us to detect potential problems and to provide effective solutions in a timely manner.
RELEASE TESTING
Testing techniques include HPLC, Mass Spectrometry,, GC, CE, UV-Vis and various wet chemical methods. Dependent on your requirements our laboratorium is capable of measuring different release methods.