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European Pharmacopoeia First Identification Requirements
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European Pharmacopoeia First Identification Requirements
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  Post Number #1  
Old 9th January 2018, 01:32 PM

Total Posts: 4
Question European Pharmacopoeia First Identification Requirements


In the general chapter of the Ph. Eur. it states that

Identification: Certain monographs give two or more sets of tests for the purpose of the first identification, which are equivalent and may be used independently.

We interpret this to be that if there are two or more tests then you only need to perform one of them for compliance.

For example if the first identification states tests A and C then we need only perform either test A or C and not both.

However the EDQM has indicated that both need to be performed and I am struggling to understand why if the tests are deemed equivalent would you need to perform both, especially as they state that the tests may be used independently.

Has anyone else got any further clarification on this subject please?

Thank you in advance.

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