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DETAILS
FUNCTION
Application
COA| Items | Specification | Result | Method |
|---|---|---|---|
| Silymarin (UV) | NLT 80.0% | 84.75% | UV || USP |
| Silymarin (HPLC) | NLT 45.0% | 47.33% | HPLC || USP |
| Sum of Silybin & Isosilybin (HPLC) | NLT 30.0% | 33.1% | HPLC || USP |
| Sum of Silybin A + Silybin B | 40~65% | 57.95% | HPLC || USP |
| Sum of Isosilybin A + Isosilybin B | 10~20% | 11.99% | HPLC || USP |
| Sum of Silycristin + Silydianin | 20~45% | 30.06% | HPLC || USP |
| Identification | A. TLC Test: Correspond to standard | Conform | TLC || USP |
| B. HPLC Identification Test: Correspond to standard | Conform | HPLC || USP | |
| PHYSICAL CHARACTERISTICS | |||
| Appearance | Yellow to light brown powder | Light brown Powder | Organoleptic |
| Particle Size | NLT 95% Through 80 mesh | 96% | Analytical sieving || USP |
| Loss on Drying | NMT 5.00% | 1.42% | USP |
| Sulphated Ash | NMT 0.50% | 0.28% | USP |
| Bulk Density | Between 0.30~0.60g/100ml | 0.462g/ml | USP Method I |
| Tapped Density | Between 0.50~0.90g/100ml | 0.866g/ml | USP Method I |
| Residual Solvent (Acetone) | NMT 5,000ppm | 3357.7ppm | GC || USP |
|---|---|---|---|
| Arsenic (As) | NMT 2ppm | <1ppm | ICP-MS || USP |
| Lead (Pb) | NMT 2ppm | <1ppm | ICP-MS || USP |
| Cadmium (Cd) | NMT 1ppm | <1ppm | ICP-MS || USP |
| Mercury (Hg) | NMT 1ppm | <0.1ppm | ICP-MS || USP |
| Total Plate Count | NMT 10,000cfu/g | <1,000cfu/g | USP |
|---|---|---|---|
| Total Yeast & Mold | NMT 1,000cfu/g | <100cfu/g | USP |
| Coliforms | NMT 10MPN/g | <10MPN/g | USP |
| E. Coli | Not Detected in(g) 10 | Not Detected | USP |
| Salmonella | Not Detected in(g) 25 | Not Detected | USP |
| Staphylococcus | Not Detected in(g) 10 | Not Detected | USP |
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