Microbiological Testing of Herbal Medicines according to European Pharmacopeia

Since April 2010, two new chapters in the European Pharmacopeia 6.7 concerning the microbiological investigation of herbal medicinal products became effective:

• 2.6.31: Microbiological examination of herbal medicinal products for oral use
• 5.1.8: Microbiological quality of herbal medicinal products for oral use

In comparison with the methods which had to be applied so far (chapter 2.6.12, 2.6.13 and 5.1.4) some changes have been implemented:

The determination of the total count of yeast and molds (TYMC) may now be performed using Sabouraud dextrose agar containing antibiotics.

In addition to the presence/absence testing of E. coli a new semi-quantitative method is described.

The limits described for for bile-tolerant gram-negative bacteria differ from those for non herbal medicinal products. Therefore the dilution steps for the semi-quantitative test are different from the ones described in chapter 2.6.13.

The absence of salmonella has to be tested in 25 g of the product. For the non-selective enrichment of Salmonella buffered peptone water is recommended instead of TSB.

All media which are new for implementation of these methods are available at heipha Dr. Müller GmbH:

• SDA with Chloramphenicol - LI (Ref. No. 03350e)
• Tryptic Soy Broth acc. EP+USP (10 ml in tubes; Ref. No. 3080r)
• buffered Peptone Water (225 ml in bottles; Ref. No. 507225)