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Impurity method development

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Impurity method development

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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

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HW Mueller
Try
http://www.sepsci.com/chromforum/viewtopic.php?t=8540

Impurity method development

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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
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