European Pharmacopoeia First Identification Requirements

[hs0wca]

Hi

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.

 

[v9991]

Hi

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?

The understanding is NOT-that they are equivalent, it is that they are "complimenting / supplementing" each other.
so the way to interpret them are that they are specific/primary and secondary identification tests.
viz., FTIR, Melting range, is different than UV / HPLC test is different than the chemical/color tests for specific comounds.

DESPITE the fact that the "certificate of analysis and certificate of conformance" are issued by the respective manufacturer,
AND DESPITE the above clarification,
various regulatory agencies insist and issue an deficiency insisting to include secondary identification test in the specification .
and hence industry practice is to include primary and secondary identification tests.[/quote]

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No, the test or tests that constitute the ‘First identification’ may be used in all circumstances. The second identification series is not intended for use in any other context than pharmacies. It may be used only if it can be demonstrated that the substance or preparation is fully traceable to a batch certified to comply with all the other requirements of the monograph.

(broken link removed) (excipients, API, medicinal products), tests as described under First identification section shall be performed. • Community and hospital pharmacies may only perform the tests as described under 2nd identification if all other tests (under Assay and Tests section) have been performed by the manufacturer of the excipient/API (and a respective CoA is available).