TABLE 4.
Recommendations (checklist of items) for most suitable analytical methods for defining the chemical profile for different types of extracts.
| Section topic | Item number a | Recommendation for conducting and reporting of analytical methods based on types of extract | ||
|---|---|---|---|---|
| Type of extract (see Figure 6) | 1 | A | B | C |
| Preferred/main methods for extract characterisation/chemical analysis (see Figure 7) | 2 | Compliance with pharmacopoeial standards to be followed: (a) Description of the active ingredients in the botanical drug (if known) or analytical marker compounds as defined | Not applicable for extract type B | Not applicable for extract type C |
| (b) An analysis as defined in the monograph is needed if the extract has not been supplied with a certificate | Not applicable for extract type B | Not applicable for extract type C | ||
| (c) If the preparation was purchased, manufacturer and certificate of analysis need to be included | Not applicable for extract type B | Not applicable for extract type C | ||
| Including either the preferred or alternative approaches for characterisation: (a) Triple chemical fingerprinting methods, each with one or more detection parameters | (a) Triple chemical fingerprinting methods, each with one or more detection parameters | Not applicable for extract type C | ||
| (b) Quantification of at least two marker compounds (unless this is not feasible evidence needs to be provided), and justification of the choice of markers (if applicable) | (b) Quantification of at least two marker compounds (unless this is not feasible evidence needs to be provided), and justification of the choice of markers (if applicable) | Not applicable for extract type C | ||
| Alternative methods for extract characterisation/chemical analysis (see Figure 7) | 3 | (a) Single chemical fingerprinting methods with at least three different detection parameters (i.e., altered detection parameters, like TLC/HPTLC with different derivatization conditions, HPLC-DAD/LC-DAD with different wavelengths). The same applies to coupling MS or NMR to chromatographic techniques | (a) Single chemical fingerprinting method, three different detection parameters should be provided (as in A) | (a) Single chemical fingerprinting methods with three different detection parameters (as in A) |
| (b) Quantification of at least two marker compounds (unless this is not feasible evidence needs to be provided), and justification of the choice of markers (if applicable) | (b) Quantification of at least two marker compounds (unless this is not feasible evidence needs to be provided), and justification of the choice of markers (if applicable) | No description of marker substances is needed but may be provided | ||
| Use of reference standards | 4 | (a) Direct overlay of the chromatogram of the sample with that of the official individual reference standards of the marker compounds | As in extract type A | As in extract type A |
| (b) Chromatographic fingerprinting: Direct overlay of the chromatogram of the sample with that of official reference standards of the powdered plant material or the dry extract from the plant material | As in extract type A | As in extract type A | ||
| Comparison of different extract/samples of the same plants | 5 | (a) Direct comparison of the chromatographic/spectroscopic system and/or scoring system for “similarity” to be followed | As in extract type A | As in extract type A |
a
As is common with other consensus statements, each item of the checklist is numbered for ease of use. The numbering will enable the authors, reviewers, and editors to quickly evaluate and find the relevant information/core items in the submitted manuscript.