At JC Analytical we have a wide experience of method development, optimisation and validation. All method validation is carried out in compliance with ICH Guidance (to ICH Q2 R1) and is supported by a full validation report on completion of the work. We can also assist with product development studies including short term accelerated stability studies.
Method development is overseen by Neil Donovan, Neil is an expert analytical chemist with over 20 years of experience covering a number of diverse sectors. He has worked on a broad range of advanced techniques such as HPLC, UPLC, LC-MS, GC-MS, GCxGC, GC-MS/MS, LC-MS/MS and ToF. Neil is a specialist in method development and validation and has presented on the topic at several international conferences. Neil is supported by a team of highly experienced analytical chemists.
We are also able to validate methods developed by other laboratories ensuring they meet the current guidelines.
Method validation requirements: as per ICH Q2 (R1) –
- Specificity
- Linearity
- Accuracy
- Repeatability
- Precision/Repeatability
- Limits of detection and quantification
- Range
- Solution stability
- Robustness
