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Name of the ingredient
Rhodiola rosea L (AHN)
Definition of the ingredient
The ingredient is obtained by aqueous or hydroethanolic (with up to 70% ethanol v/v) extraction of the powdered dried root (rhizome) of R. rosea L only, and not from the root of any of the related species, such as R. crenulata (Hook. f. & Thomson) H. Ohba and R. sacra (Prain ex Raym.-Hamet) S.H. Fu. The typical native extraction ratio range is 6–10:1 for aqueous extraction and 3–5:1 for hydroethanolic extraction.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Characteristics | ||
| Identification | ||
| Assay | ||
| Appearance | Visual | Brown, non-crystalline powder |
| Odour | Organoleptic | Rose-like |
| Loss on drying | BP (Appendix IX D) | Not more than 5% |
| Chemical fingerprint1 | HPLC | Complies with authenticated reference material |
| Phenylpropanoids2 | HPLC | 3.0-5.0% |
| Rosavin3 | HPLC | 1.5-3.5% |
| Salidroside4 | HPLC | 1.0-3.0% |
Notes
- Test must be validated and capable of discriminating between R. rosea and related species especially R. crenulata and R. sacra. The suggested method is that by Ganzera et al. (2001) Chemical and Pharmaceutical Bulletin 49(4): 465-467. The HPLC profile should be compared against the 'fingerprint' of a genuine standard R. rosea extract, to not only confirm identity but also to determine if any additional peaks are those of potential contaminants. If the comparator 'fingerprint' is not available, the identity of peaks cannot be determined simply based on their retention time. In order to confirm the identity of each peak, peaks should be collected and specific characterisation performed (e.g. GC-MS, NMR or IR spectrum).
- The term "phenylpropanoids of R. rosea" comprises the sum of the compounds rosavin, rosarin and rosin.
- Rosin = 3-phenyl-2-propeny1-O-β-d-glucopyranoside
- Rosavin = 3-phenyl-2-propeny1-O-(6'-O-α-l-arabinopyranosyl)-β-d-glucopyranoside
- Rosarin = 3-phenyl-2-propeny1-O-(6'-O-α-l-arabinofuranosyl)-β-d-glucopyranoside.
- The term "rosavin" refers specifically to 3-phenyl-2-propeny1-O-(6'-O-α-l-arabinopyranosyl)-β-d-glucopyranoside. The test must be capable of discriminating this compound separately from other phenylpropanoids.
- A salidroside content in excess of the phenylpropanoid content is anomalous and may suggest that a preparation is not pure R. rosea extract.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Residual solvents | ||
| Incidental metals and non-metals | ||
| Pesticide residues and environmental contaminants (including agricultural and veterinary substances) | ||
| Microbiology | ||
| Residual solvents | BP (Appendix VIII L) | Complies |
| Heavy metals (as lead) | BP (Appendix VII) | Not more than 10 ppm |
| Pesticide residues | BP (Appendix XI L) | Complies |
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
Key to abbreviations
BP = British Pharmacopoeia
HPLC = High-pressure liquid chromatography