Standardization

Standardization has become a major trend in the herbal products industry as well as research organizations (Roll, 2002; Tierra, 1999; Vlietinck, 2002). The first step in conducting quality control of Echinacea products is to establish true botanical identity and safety of its raw plant material by comparison with authenticated reference plant material (ARPM), which aids in the identification of adulterants (Roll, 2002). It is expected that a "certificate of botanical identity" will eventually be required for all sales of Echinacea. For standardization of Echinacea cultivation, especially for determining optimum harvest time, practice-relevant results are needed, including botanical characteristics (macroscopic and microscopic) (Giancaspro, 2000), gross physical determinants of quality, and widely accepted quality criteria relating to chemical content. Strict quality controls are required for the Echinacea plant raw materials with regard to homogeneity and purity of the raw material, minimum content of effective components, and limit values for plant-protective agent residues and microbial contamination.

A number of quantitative standards for Echinacea roots already exist. The USP typically specifies maximum water content of 10%, total ash content of up to 7%, not more than 3% of foreign organic matter, not more than 4% of acid-soluble ash, and not more than 0.001% of heavy metals (Giancaspro, 2000). The chemical identification of Echinacea roots has been intensively studied and could be performed by a specific procedure of the TLC test (Giancaspro, 2000) (Table 9.12) and HPLC analyses (Perry et al., 2001).

Numerous tests can be used to evaluate the quality and purity of end products in Echinacea. First, the physical characteristics of the extract, including appearance, pH, solubility, content of

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