From: Key quality factors for Chinese herbal medicines entering the EU market
Items | Classifications | Characteristics |
---|---|---|
Based on chemical constituents/markers | Standardized extracts | 1. Chemical constituents/markers with known therapeutic activity 2. A defined content, single content or single content in a defined range, of one or more the active chemical constituents/active markers, with acceptable tolerance within the range ± 5% to ± 10% taking into account the nature of the extract and the method of assay 3. Blending batches of the extract, or adjustment with inert excipients, is available |
Quantified extracts | 1. A limited and specified range of content with one or more active markers 2. Blending batches of the extract is available | |
Other extracts | The minimum content for one or more analytical markers is required | |
Based on physical states | Liquid extraction preparation/liquid extracts | 1. Standardized liquid extracts 2. Quantified liquid extracts 3. Other liquid extracts |
Liquid extraction preparation/tinctures | 1. Standardized tincture 2. Quantified tinctures 3. Other tinctures | |
Soft extracts | Semi-solid preparations obtained by evaporation or partial evaporation of the solvent used for production | |
Oleoresines | Semi-solid extracts composed of a resin in solution in an essential and or fatty oil | |
Dry extracts | Solid preparations by evaporation of the solvent with a loss on drying of not greater than 5% m/m, where justified and authorized, with a different limit available |