http://blog.pharmtech.com/2010/06/15/requirements-for-extractables-leachables-can-be-confusing-to-say-the-least/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2010/06/15/requirements-for-extractables-leachables-can-be-confusing-to-say-the-least/comment-page-1/#comment-43957 Arthur Montague Fri, 24 Feb 2012 10:56:32 +0000 http://blog.pharmtech.com/?p=2961#comment-43957 I just came across this webpage, whilst researching current thinking on E&L. I'm a bit confused, because contrary to the first paragraph of this article, Q3B(R2), p.1, states "Impurities arising from excipients present in the new drug product or extracted or leached from the container closure system are not covered by this guideline.." I just came across this webpage, whilst researching current thinking on E&L. I’m a bit confused, because contrary to the first paragraph of this article, Q3B(R2), p.1, states “Impurities arising from excipients present in the new drug product or extracted or leached from the container closure system are not covered by this guideline..”

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