
| Item | Specification |
| CAS no. | 84604-20-6 (Silybum marianum extract) |
| Botanical kind | Asteraceae (=Compositae) Silybum marianum (L.) Gaertn. |
| Part of the plant | Dried fruit (akene) |
| Extraction solvent(s) | Ethanol |
| Carrier(s) | None |
| Appearance | Thin hygroscopic powder |
| Color | Light yellow to brown yellowish |
| Odor | Characteristic |
| Taste | Characteristic |
| Solubility | To be tested following the degree of incorporation |
| Total silymarin expressed as silibinin content [%] | 50.00 – 80.00 (HPLC, Ph. Eur. monograph) |
| Identification (finished product) (4) | Complies (TLC, Ph. Eur. monograph) |
| Ethanol residual content [%] (2) | Max. 0.50 |
| Hexane residual content [%] (2) | Max. 0.03 |
| Ethyl acetate residual content [%] (2) | < 0.50 |
| Loss on drying [%] (11) | Max. 5.00 |
| Screening [% < 177 µm] | Min. 90.0 |
| Pb content [ppm] (4) | < 0.50 |
| Cd content [ppm] (4) | < 0.50 |
| Hg content [ppm] (4) | < 0.50 |
| As content [ppm] (4) | < 1.00 |
| Pesticides content [ppm] (4) | < Residual Maximum Limit fixed in European regulation 396/2005 and its modifications |
| Benzo(a)pyrene content [ppb] (4) | < 10.0 |
| Pahs (sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene) content [ppb] (4) | < 50.0 |
| Total aerobic microbial count [CFU/g] (1) | < 10 000 |
| Total yeasts/moulds count [CFU/g] (1) | < 100 |
| Salmonella content [/25g] | Absent |
| Bile-tolerant Gram negative bacteria content [CFU/g] | < 10 |
| Escherichia coli content [/g] | Absent |
| Staphylococcus aureus content [/g] | Absent |
| Best before (months) | 24 |
| Storage conditions | Store in closed original packaging at 5 to 25°C in a dry place and protected from light. |



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