EP 2.6.31. Microbiological Examination of herbal medicinal Products for oral Use under Revision

In 2010 the monopraphs for herbal medicinal products had undergone several changes - as reportet in our GMP News fom 31 March 2010. Now the EDQM announced that the monograph 2.6.31, published in supplement 6.7, is under revision.

This chapter was implemented by the following history:
The semi-quantitative test for E. coli (probable number method) is the same as the one currently described in the Appendix (special Ph. Eur. provision) to the harmonised chapter 5.1.4. Since herbal drugs are outside the scope of pharmacopoeial harmonisation this test has been transferred into the present chapter.

The absence test for E. coli and the semi-quantitative test for bile-tolerant gram-negative bacteria (probable number method) are the same methods as those currently published in the harmonised chapter 2.6.13. It is proposed also to describe them in the present chapter. The proposed method for Salmonella (test for absence) is similar to the method currently published in chapter 2.6.13 but the proposed method was adapted to the increased sample size (25 g or 25 ml instead of 10 g or 10 ml), shown to be appropriate for herbal medicinal products. For herbal medicinal products with naturally high bioburden the use of buffered peptone medium instead of casein soya bean digest broth is reasonable because of higher buffer capacity.

More information can be found at EDQM's Knowledge Database.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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