by
shaun78 » Mon Feb 25, 2008 5:32 pm
This is a little bit of a grey area. I have not found too much information on KF validations out there.
I have, however, done this in the past, and I believe that the work has been submitted to the FDA for some NDA's/ANDA's that companies I have worked for have submitted. I was never told that the FDA staid anyhting about the KF work I performed.
So, this is what I would do:
1. Six replicated at nominal concentrarion. Acceptance criteria: SD or RSD of n=6 must be not more than 0.2 and/or 10%, respectively.
2. Linearity evaluation spanning from 50% to 150% of nominal. R must be greater than 0.98.
3. Evluation of time spent in the cell regardless of when the titration was started had no significant effect upon moisture tests across different lots of the API*.
4. Evaluation that the API is soluble in the medium chosen at concentrations 200% greater than nominal and across different lots of the API*.
5. Statment on why medium chosen and titrant selected is appropriate based upon chemical srtucture of API.
* it is really nice if you are able to get lots of the API that are both high (near failure for spec) and low for moisture. This way you can show the test will work for the range of your spec.
I hope this helps.
