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Table 1 Herbal extracts in the Ph. Eur

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