(1) Manufacturing data
Botanical name: Silybum marianus Gaertner
Part of plant used: Fruit without pappus
Method of manufacturing: Macerationx-reflux
Solvent for Extraction: Acetone
Carrier / Excipient: Maltodextrin
Ratio of botanical to native extract: 20~35:1
(2) Quality data
1) Physical and chemical data
Appearance: Oily Extract
Color: brown to brownish
Odor: Characteristic
Taste: Characteristic
Solubility: Dissolve in ethanol
Moisture: NMT 5.0% (2 h at 105°C)
Ash: NMT 10.0%
Identificatio by TLC: Complies to standard;
Quantitative determination: NLT 80% Silymarin by HPLC
2) Safety Data
Microorganism:
Total plate count: NMT 1,000/mg
Yeast & Mold: NMT 100/mg
E. coli: Negative
Salmonella: Negative
Other hazardous substance:
Arsenic: NMT 5ppm
Heavy Metal: NMT 10ppm
3) Package/ Storage
Storage: Cool, dry area; in sealed container
Shelf life: Typically 24 months unopened