Dear, good afternoon
I am writing from chile
That I can modify an analytical methodology and remains pharmacopoeia?
In specific modifications made they included:
- Increased HPLC injection volume (of 50uL to 80uL)
- Change 30cms to 15cms column (same type)
- Flow 2ml / min at 0.8ml / min
Applies perform a complete validation
or just a verification of the methodology???
there is a guide in which I can support
thank you very much