Chromatography Forum

Chromatography Forum is a public discussion group where you can post questions, news, or messages of interest to chromatographers everywhere, but you must be registered to participate (registration is FREE). If you are a registered user, please log in.
http://www.chromforum.org/

Impurity method development

http://www.chromforum.org/viewtopic.php?t=8569

Page 1 of 1

Impurity method development

Posted: Thu Jun 05, 2008 6:45 pm
by Apple_insci
Can someone tell me how to develop an impurity HPLC method for a new drug entity? I will have to do for an API impurity method, do I have to spike in all the intermediates or maybe starting materials. Can I only deal with API itself? If there any guideline for such kind method development?

Thanks in advance -Apple

Posted: Fri Jun 06, 2008 8:02 am
by HW Mueller
Try
http://www.sepsci.com/chromforum/viewtopic.php?t=8540

Impurity method development

Posted: Fri Jun 06, 2008 8:43 am
by scottythree
For what to prove and if you are GMP compliant you should reference the ICH
guidelines Q3 (A,B and C).

http://www.ich.org/LOB/media/MEDIA422.pdf

http://www.ich.org/LOB/media/MEDIA421.pdf

http://www.ich.org/LOB/media/MEDIA423.pdf
All times are UTC
Page 1 of 1
Powered by phpBB® Forum Software © phpBB Limited
https://www.phpbb.com/