Whitepaper for Method Development
Strategies for Preparative LC
The objectives for method developers in preparative LC are:
Purification and isolation of a target compound with a maximum sample amount in the shortest cycle time under cost pressure. Whereas isolation focuses on the scale up of mg- to g-units, the production scale needs to achieve up to kilograms or even tons.
The most comprehensive approach for method development in preparative LC is the so-called linear scale-up, which consist of:
- Method development at analytical scale
- Loadability studies on analytical scale
- Scale-up to preparative process
- Regulatory Affairs Support
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