Microbiological Control of Herbal Drugs

With the forthcoming of the supplement 7 of the Ph. Eur.6 (European Pharmacopoeia), which is binding as of April 2010, several changes are in the offing for the microbiological control of herbal drugs. With the chapter 5.1.8., this applies to drugs for oral intake such as alcoholic extracts, medicinal teas and agents from dried plants for example. Here the chapter discloses the new categories - A,B,C - for oralia of herbal origin.

Furthermore, herbal preparations in the table belonging to chapter 5.1.4. have been removed, which are now classified in chapter 5.1.8. in the categories A, B, C. As a result, this leads to changes e.g. for the specifications of former 4A and 4B products but also regarding the inspection for salmonellae, which must now must be inspected in 25 g resp. ml. In the specification factor 5 applies again for the "Total Aerobic Microbial Count (TAMC)" and the "Total Combined Yeast and Mould Count (TYMC)".

In the new chapter 2.6.31 the inspections for herbal drugs with particular specifications for Escherichia coli, salmonella and gram-negative bacteria are specified with bile salt tolerance. Important is that when testing for TYMC the application of antibiotics in a Sabourand agar is permitted in order to prevent bacterial growth.

Among other things, the "3rd European Microbiology Conference" from May 4th - 5th in Barcelona offers a lecture about the current challenges due to the harmonised microbiological inspections and methods for herbal drugs.

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