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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