News
20.03.2025 - Cosmetics
Microbiological examination of herbal medicinal products – Examination according to Ph.Eur.
The microbiological quality of herbal medicinal products is a crucial factor for product safety. The European Pharmacopoeia (Ph. Eur.) specifies specific limits and methods for microbiological testing in Chapter 5.1.8.
The methods used include total viable count determination, detection of specific pathogenic germs, and quantitative tests for bacteria, fungi, and yeasts. Among others, the pour plate method, membrane filtration, and the Most Probable Number (MPN) method are used. Particularly critical are potentially dangerous microorganisms such as Escherichia coli, Salmonella spp., or Staphylococcus aureus.
Ph. Eur. 5.1.8 divides herbal medicinal products into the following product categories with specific microbiological requirements:
- Category A: Products used with boiling water
- Category B: Products where limited microbial contamination is acceptable
- Category C: Products with higher microbial limits
Compliance with these microbiological standards ensures the safe use of herbal medicinal products and is mandatory for manufacturers.
We test the microbiological quality of herbal medicinal products quickly and reliably. Upon request, we conduct germ identification using MALDI-TOF.
Source: www.ecv.de