Theme V: Drug analysis methods
The test for determination of microorganisms consists to a microbiological sowing according to the specified in the Pharmacopoeia.
Herbal medicinal products belong to category 4 of the British Pharmacopoeia consisting of one or more herbal drugs (whole, reduced or powdered).
There are two categories: A and B
A-herbs added to boiling water to be taken (infusion)
1 - total viable aerobic count. Limit no more than 107 aerobic bacteria and no more than 105 fungi per gram or per milliliter of solution.
2 - No more than 102 E. coli per gram or per milliliter.
B- Herbs which
no boiling water is added to them before use.
1 - total viable aerobic count. Limit no more than 105 aerobic bacteria and fungi not more than 104 per gram or per milliliter.
2 - No more than 103 enterobacteria and other Gram-negative bacteria per gram or per milliliter.
3 - Absence of Escherichia coli per gram or per milliliter.
4 - Absence of Salmonella in 10 grams or 10 ml.
Visual examination and microscopic inspection of herbal drugs
Determination of foreign matter
Determining extractable substances
Determination of volatile oils
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