Some monographs on certain substances concerning the limit for unspecified impurities published in Ph. Eur. 7.0, 7.1 and 7.2 have been modified. This limit has been set at 0.10% instead of 0.1%. In an announcement from 5 April, the EDQM pointed out that these monographs do not appear in the list of corrected monographs. As a consequence, some CEPs referring to these monographs and granted before the implementations of their correction may also include a limit for unspecified impurities set at 0,10%, which has therefore become redundant with the one of the monograph. These CEPs will be updated progressively in the context of their next revision.
Most of the corrected monographs (in total 30) can be found in Ph. Eur 7.0. Three other monographs were published in the 7.1 edition and one in the 7.2 edition.
The EDQM requests from all applicants who submit a CEP application to take into account the new limit for unspecified impurities which are affected by the revised monographs.
Please also see the list of substances for which the corresponding monographs were revised. can be found here.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Note: The ECA Education Course "Impurities" in Budapest, Hungary, from 25-27 May 2011 will focus on analytical methods for detection and specifications for impurities.