Apihepar Darsil Flavobion
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Product Name: |
Milk Thistle Seed Extract (Silymarin 80% by UV) |
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CAS: |
65666-07-1 |
Batch No.: |
SM240408C |
Botanical Source: |
Silybum marianum (L.) Gaertn |
Plant Parts: |
Seeds |
Manufacture Date: |
Apr. 17, 2024 |
Expired Date: |
Apr. 16, 2027 |
Non-Irradiated/Non-ETO/Treat by Heat Only |
Solvents: |
Acetone and Hexane |
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Analysis Item |
Specification |
Result |
Method |
Silymarin |
≥ 80.0% |
80.35% |
UV-Vis |
|
Report |
31.95% |
HPLC |
Silybin & Isosilybin |
-- |
18.77% |
HPLC |
Silybin |
-- |
12.65% |
HPLC |
Appearance |
Yellowish-brown powder |
Complies |
Visual |
Odor |
Characteristic |
Complies |
Organoleptic |
Identification |
Positive |
Complies |
TLC |
Powder Size |
≥ 95% through 80 mesh |
Complies |
USP #80 Sieve |
Bulk Density |
0.30 – 0.60 g/mL |
0.45 g/mL |
USP-NF<616> |
Tapped Density |
0.50 – 0.80 g/mL |
0.63 g/mL |
USP-NF<616> |
Loss on Drying |
≤ 5.0% |
3.23% |
USP-NF<731> |
Residue on Ignition |
≤ 0.5% |
0.29% |
USP-NF<281> |
Residual Acetone |
≤ 5,000 μg/g |
13 μg/g |
USP-NF<467> |
Residual Hexane |
≤ 290 μg/g |
4 μg/g |
USP-NF<467> |
Residual Ethanol |
≤ 5,000 μg/g |
1339 μg/g |
USP-NF<467> |
Pesticide Residues |
USP<561> |
Complies |
USP-NF<561> |
Total Heavy Metals |
≤ 10 μg/g |
Complies |
USP-NF<231> |
Arsenic (As) |
≤ 1.0 μg/g |
ND (< 0.1 μg/g) |
ICP-MS |
Cadmium (Cd) |
≤ 0.5 μg/g |
ND (< 0.01 μg/g) |
ICP-MS |
Lead (Pb) |
≤ 1.0 μg/g |
ND (< 0.1 μg/g) |
ICP-MS |
Mercury (Hg) |
≤ 0.1 μg/g |
ND (< 0.01 μg/g) |
ICP-MS |
Total Plate Count |
≤ 1,000 cfu/g |
< 10 cfu/g |
USP-NF<2021> |
Molds and Yeasts |
≤ 100 cfu/g |
5 cfu/g |
USP-NF<2021> |
Salmonella |
Absence/ 10g |
Complies |
USP-NF<2022> |
E. Coli |
Absence/ 10g |
Complies |
USP-NF<2022> |
Staphylococcus aureus |
Absence/ 10g |
Complies |
USP-NF<2022> |
Aflatoxin B1 |
≤ 2μg/kg |
ND(< 0.5 μg/kg) |
USP-NF<561> |
Aflatoxins (B1,B2,G1,G2) |
≤ 4μg/kg |
ND(< 0.5 μg/kg) |
USP-NF<561> |
Packing: |
25 kg/drum, |
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Packing in a sealed aluminum foil bag with a sealed plastic-bag outside |
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Storage: |
Store in a well-closed container away from moisture, direct light and heat. |
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Expired date: |
Re-test after three years from the manufacturing date. |
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