-
- Posts: 2
- Joined: Mon Aug 12, 2019 3:59 pm
Is it possible to change formulation buffer being used while method was validation earlier? In what situation, we can go for replacing the old buffer with new ?
Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.
The short answer is "no". The method must be validated as written. If you change the buffer midway through the validation, the relevant portions must be revalidated.Is it possible to change formulation buffer being used while method was validation earlier?
Per the above comment, changing the buffer is a "modification" of the method. A modified method must be revalidated.In what situation, we can go for replacing the old buffer with new ?
What you (or I) *think* is irrelevant. The only way to *know* is to run the validation. That's what validation is all about.I think to go from complex to the simpler matrix, the validation wouldn't have any big impact.
Separation Science offers free learning from the experts covering methods, applications, webinars, eSeminars, videos, tutorials for users of liquid chromatography, gas chromatography, mass spectrometry, sample preparation and related analytical techniques.
Subscribe to our eNewsletter with daily, weekly or monthly updates: Food & Beverage, Environmental, (Bio)Pharmaceutical, Bioclinical, Liquid Chromatography, Gas Chromatography and Mass Spectrometry.