Review of Supplement 6.8 European Pharmacopeia 6th Edition

Chapter 2.6.1. Sterility and  Chapter 2.6.12. Microbiological examination of non-sterile products: microbial enumeration test has been changed. The Name of Aspergillus niger, one of the Strains of the test micro-organisms suitable for use in the growth promotion test and the method (Table 2.6.1.-1) has been changed to Aspergillus brasiliensis.

This change is caused by the following announcement which has been recently published on the ATCC website:
“Strain ATCC® 16404TM, currently known as Aspergillus niger, has been designated as a quality-control reference strain in a number of applications. It is also cited as the standard culture in several official methods (USP) and manuals, as well as the Code of Federal Regulations. Recently, a polyphasic study was performed at ATCC in which molecular data was combined with physiological characteristics. The results clearly indicate that ATCC®16404TM is a member of the novel species Aspergillus brasiliensis. Thus, we are renaming ATCC®16404TM as Aspergillus brasiliensis and will be notifying users worldwide of this name change. A recent publication [Varga et al., International Journal of Systematic and Evolutionary Microbiology (2007) 57: 1925-1932] describes the novel species. ATCC® 9642TM, deposited as Aspergillus niger, is also being renamed as Aspergillus brasiliensis.”

This reclassification necessitated the replacement of Aspergillus niger with Aspergillus brasiliensis in the present chapter. But it has no impact on the characterization of the organism and of the performance of the test.

The 3rd European Microbiology Conference in Barcelona, Spain, from 4-5 May 2010 provides you with an insight in the current changes in the taxonomy of microorganisms and the developments in pharmaceutical microbiology.

Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)


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