By Anonymous on Friday, March 5, 2004 - 05:00 am:
Hi Everyone
I'm in the process of updating our method validation protocol and I was wandering if you could give me some advice. Our protocol is fine as far as specificity, linearity, accuracy, lod, loq. etc. There seems to a "gray" area as far as our method precision is concerned.
1) Repeatability - Requirements: The %RSD of six sample preps N.M.T 3.0%
2)Intra-lab precsion - Requirements: The %RSD of six sample preps N.M.T 3.0%, The mean results between the (1) and (2) does not differ by more than 4.0%.
3)Inter-lab precision - Requirements: The %RSD of six sample preps N.M.T 3.0%, The mean results between the (1) and (3) does not differ by more than 5.0%.
Do you think these limits are too conservative or do we need to increase them. NB: concentration of impurities - 0.1 to 1.0% with respect to the active.
Many thanks
By Anonymous on Friday, March 5, 2004 - 01:49 pm:
I think your limits are too conservative. We generally use 10% difference.Are you working on pharmaceutical drugs? There is a ICH guideline to use to calculate % Label Claim, then using these to calculate the % difference in % Label Claim. The specifications required is in the guidelines.
By Anonymous on Sunday, March 7, 2004 - 09:38 pm:
Hi
Yes, we are working with pharmaceutical drugs. I'll check the ICH guidelines with regard to impurities.
Thanks
By Anonymous on Monday, March 8, 2004 - 02:35 am:
hi every body
how to start the validation work in gc please give the list of requirements for this analysis
thanx
By Anonymous on Monday, March 8, 2004 - 02:40 am:
hi
What is mean by Carbon load in hplc Column
Thanks
By Anonymous on Monday, March 8, 2004 - 03:25 am:
urgent anyone pl.help
By Anonymous on Monday, March 8, 2004 - 03:37 am:
I've checked the ICH website but can't find the guidline..Do you a link for it
Thanks
By Anonymous on Tuesday, March 9, 2004 - 01:45 pm:
http://www.ich.org/UrlGrpServer.jser?@_ID=363&@_TEMPLATE=272
By Alex on Thursday, March 11, 2004 - 12:22 am:
To the original anonymous:
There are no acceptance criterie given in the ICH Guide Q2A&B. Your criteria are acceptable (personal opinion). Beside the concentration of impurity also the amount of drug substance shoud be considered there is a difference between 500 mg acetyl salicylc acid tablets and pharmaceutical that are dosed in the µg- or sub-µg-range.
By Anonymous on Thursday, March 11, 2004 - 10:27 pm:
Hi Alex
Thanks for your imput. It's nice to get a "second" opinion. I've checked the ICH guidelines again and can't find any acceptance criteria.
Thanks everyone for your comments.