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Chemistry Forums for Students => Analytical Chemistry Forum => Topic started by: cristvenegas9665 on August 23, 2016, 03:58:30 PM

Title: Validation methodologies
Post by: cristvenegas9665 on August 23, 2016, 03:58:30 PM

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

Greetings!!!

Title: Re: Validation methodologies
Post by: Arkcon on August 23, 2016, 08:01:50 PM

People have at times claimed both options.  Look carefully at the relevant pharmacopia:  does it explicitly state that those changes are allowed?  The last ione, 2 ml/min to 0.8 mL/min seems to far to allow a simple verification, and requires validation.  But another expert may have some support verification.