Method development & validation
The development of a robust, selective, stability indicating method to determine compound purity is fundamental to the development of any API. The Brightlabs team has developed hundreds of methods across many different compound classes, including highly complex multi-stereocentre natural product derivatives.
As the development programme progresses and more knowledge regarding the process and the compound characteristics is gained, so the supporting analytical methods are developed, and eventually subject to full validation. Brightlabs is experienced in full validation programmes and able to provide data to support the regulatory filing.
Steps during method validation
- Writing a phase appropriate method validation protocol (ICH Q7 chapter 19)
- Practical experiments
- Writing a phase appropriate method validation report (ICH Q7 chapter 19)
- Analytical method including system suitability
PGI methode development
- (u)HPLC –QQQ-MS ESI source
- HPLC with pre column derivatisation
- GC-QQQ-MS (EI source)
- GC-QQQ-MS (CI source)
Automatic method development can do everyone
Fine-tuning a separation is an art!