Transcription of General Concepts in the European Pharmacopoeia
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General Concepts in the European Pharmacopoeia
General Concepts in the European Pharmacopoeia General Concepts in the European PharmacopoeiaAnne-Sophie BouinEuropean Pharmacopoeia Department, EDQM, Council of EuropeAnne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All rights reserved1 General noticesAnne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All rights reserved2 General NoticesGeneral NoticesPut at the very beginning of the Ph. Eur. (page 1), they address General issues and are aimed at providing the basic information to the user Apply to alltexts Rules to understand texts, conventional expressionsEssential reading before starting to use monographsAnne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All rights reserved3 Typical questions that are answered in the General Notices Typical questions that are answered in the General Notices Do specifications apply throughout shelf-life?
capsules, parenteral ... European Pharmacopoeia … has been prepared by a method liable to leave impurities not controlled in the pharmacopoeia monograph, these impurities and their maximum tolerance limits must be declared and a suitable test procedure must
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