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Product Name | Berberine HCI | Country of Origin | China | |||
Item | Specification Results | Method | ||||
Assay | ≥97.0% | HPLC | ||||
Physical Control | ||||||
Appearance | Fine Powder | Visual | ||||
Color | Yellow | Visual | ||||
Odor/ Taste | Characteristic | Organoleptic | ||||
Particle Size | 70% pass 40mesh | GB5507-85 | ||||
Identification | Positive | TLC | ||||
Loss on Drying | ≤5.0% | 5g/100℃/2.5hrs | ||||
Ash content | ≤5.0% | 2g/525℃/3hrs | ||||
Extract Solvent | Ethanol:Water=7:1 | \\ | ||||
Solvents Residue | Water | USP | ||||
Heavy metals | ||||||
Total Heavy Metals | ≤10ppm | ICP/MS | ||||
Lead | ≤2ppm | ICP/MS | ||||
Arsenic | ≤2ppm | ICP/MS | ||||
Mercury | ≤1ppm | ICP/MS | ||||
Cadmium | ≤1ppm | ICP/MS | ||||
Microorganism Control | ||||||
Total aerobic microbial count | ≤1,000cfu/g | USP<2021> | ||||
Total yeast and mould count | ≤100cfu/g | USP<2021> | ||||
E coil | Absent in 10 g or 10 mL | USP<2022> | ||||
Salmonella spp | Absent in 1 g or 1 mL | USP<2022> |
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