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On the 20th of October 2010, the European Medicines Agency (EMA) published the document 41500/2010 containing interesting Questions and Answers on quality of herbal medicinal products/traditional herbal medicinal products. In total, you can read answers to 26 different questions on the following fields: - Specification of the finished product
- Testing
- Contaminants (Mycotoxins)
- Microbiological quality
- Fumigants
- Manufacture
- Quality of water
- Stability
Stability has been the most asked subject with 12 questions. Here are 2 examples: Question 25:
Is one type of chromatographic fingerprint sufficient for stability testing of the finished product? Answer:
Yes, in most cases. If more than one group of constituents is known to contribute to the activity of the active substance, the fingerprints should cover all the groups. Question 26:
Are stability overages for herbal active substances acceptable? Answer:
In general, as the whole herbal substance/preparation is considered as the active substance, stability overages wouldn't be acceptable. However, stability overages would be acceptable for standardized extracts if justified. You may want to find more - here's the complete Q&A document.. Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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