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Dear Ohlbe,
I could imagine that the primary standard does not need a certificate of analysis and the content of the substance is given simply by the assigned value. This would resemble the previous definition of a length unit meter, which was specified as a length of prototype meter standard stored in France. In most cases, the EDQM specifies at least this assigned value. But recently we have bought a standard of perindopril tert-butylamine and in this case no assigned value is specified.
Generally it seems me that the EDQM did not cooperate well in this case with EMA. The Guideline on bioanalytical method validation specifies the EPCRS as a first choice, but EDQM states that "The EDQM Reference Standards are established exclusively for the intended use(s) described in the official texts of the Ph. Eur.". These statements are contradictory and should be harmonized.
Best regards,
Jan
I could imagine that the primary standard does not need a certificate of analysis and the content of the substance is given simply by the assigned value. This would resemble the previous definition of a length unit meter, which was specified as a length of prototype meter standard stored in France. In most cases, the EDQM specifies at least this assigned value. But recently we have bought a standard of perindopril tert-butylamine and in this case no assigned value is specified.
Generally it seems me that the EDQM did not cooperate well in this case with EMA. The Guideline on bioanalytical method validation specifies the EPCRS as a first choice, but EDQM states that "The EDQM Reference Standards are established exclusively for the intended use(s) described in the official texts of the Ph. Eur.". These statements are contradictory and should be harmonized.
Best regards,
Jan
Complete thread:
- Reference standards janmacek 2015-02-13 10:57 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reference standards ElMaestro 2015-02-13 11:51
- OECD GLP Helmut 2015-02-13 14:13
- Reference standards Ionsource 2015-02-16 08:04
- Reference standards Ohlbe 2015-02-13 15:49
- Reference standards nobody 2015-02-13 19:22
- Reference standards ElMaestro 2015-02-13 23:00
- ....got a wicked idea ElMaestro 2015-02-13 23:18
- ....got a wicked idea nobody 2015-02-14 12:49
- ....got a wicked idea ElMaestro 2015-02-13 23:18
- Reference standards ElMaestro 2015-02-13 23:00
- Reference standardsjanmacek 2015-02-16 12:59
- Reference standards janmacek 2015-07-15 09:28
- "solved" ??? ElMaestro 2015-07-15 10:35
- Reference standards janmacek 2015-07-15 09:28
- Reference standards nobody 2015-02-13 19:22
- Reference standards ElMaestro 2015-02-13 11:51
Ing. Helmut Schütz