quality control of crude and powdered drugs

monographs of the European pharmacopoeia relating to herbals

about 12% of Ph. Eur. texts are directly related to herbals

• general monographs on herbal drugs and herbal drug preparations (e.g. herbal teas, extracts, essential oils)

• monographs on specific herbals e.g. melissa leaf, liquorice root)

• 85 monographs on herbal drug preparations e.g. ginseng dry extract, anise oil)

• 23 general methods for pharmacognosy e.g. ash insoluble in hydrochloric acid, pesticide residues)

• general chapter on the microbiological quality of herbal medicinal products for oral use and extracts used in their preparation

authenticity, quality, purity of crude drugs

correct identification of raw material crucial

natural variation means standards lower than allopathic substances

standards and limit tests

• assays: chemical, physical or biological

• macroscopical and organoleptic examination

• microscopical examination

foreign matter (B.P.Appendix XI D)

related plant parts

other foreign organic matter

method: thin layer of material is examined at 6x magnification and quantified

moisture content

must be minimized to avoid enzymatic deterioration, microbiological attack

several methods of determination

• determination of water (B.P.Appendix IX C)

• loss on drying (B.P.Appendix IX D)

determination of water

chemical determination: karl-fischer titration

separation and measurement of water

• distillation using a Dean-Stark type apparatus

• GC

Coulometric titration

• electrochemical