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TOPICS : 04- EUROPEAN PHARMACOPOEIA & INTERNATIONAL HARMONISATION / 01- General Chapters and Monographs  / 02- COMPLIANCE WITH A MONOGRAPH 

• 01. If I analyse a substance according to a Ph. Eur. monograph, do I also need to demonstrate compliance with the national monograph?

• 02. If I analyse a substance according to a national monograph, do I also need to demonstrate compliance with a Ph. Eur. monograph?

• 03. How can I find the reference number, exact name or status of a European Pharmacopoeia monograph for a particular substance?

• 04. How can I know if a monograph is present in the Ph. Eur.?

• 05. How can I obtain the official analytical methods of the European Pharmacopoeia? Could you send me a PDF file, for example?

• 06. Do I need to validate a method that is published in the Ph. Eur.?

• 07. Can I use a reagent or method other than the one published in Ph. Eur.?

• 08. When can I apply the tests and specification of a new monograph and those of a revised monograph?

• 09. What is a ‘nominal value’ in the Ph. Eur. texts?

• 10. What is a ‘stated potency’?


 
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