Certificate of Analysis
|
Product Name |
Betulin |
Country of Origin |
China |
|
Botanical Source |
Betula Platyphylla |
Part Used |
Bark (100% Natural) |
|
Batch No. |
BHZC-200620 |
Batch Quantity |
100KGS |
|
Manufacturing Date |
Jun 20, 2020 |
Expiry Date |
Jun 19, 2023 |
|
Sterilization Method |
Heat || NON-IRR |
Kosher || Halal |
Yes |
|
Items |
Specification |
Result |
Method |
|
Content |
Betulin≥98% |
99.1% |
HPLC || USP |
|
Identification |
Positive |
Positive |
FT-IR |
|
Physical Characteristics |
|||
|
Appearance |
White to off-white Fine free-flowing powder |
Conform |
Visual |
|
Odor& Taste |
Characteristic |
Characteristic |
Organoleptic |
|
Loss on Drying |
≤2.0% |
0.81% |
USP <731> |
|
Residue on ignition |
≤0.5% |
0.27% |
USP <561> |
|
Bulk Density |
40~60 g/100ml |
47.8g/100ml |
USP <616> Method I |
|
Particle Size |
100% Through 80 mesh |
100% |
Analytical sieving || USP <786> |
|
Chemical Characteristics |
|||
|
Heavy Metals (as Pb) |
≤ 10ppm |
<10ppm |
USP <231> Method II |
|
Arsenic (As) |
≤ 1ppm |
<1ppm |
ICP-MS |
|
Lead (Pb) |
≤ 1ppm |
<1ppm |
ICP-MS |
|
Cadmium (Cd) |
≤0.05ppm |
<0.05ppm |
ICP-MS |
|
**(Hg) |
≤0.2ppm |
<0.2ppm |
ICP-MS |
|
Microbiological Characteristics |
|||
|
Total Plate Count |
NMT1000cfu/g |
Conform |
USP<61> |
|
Yeast & Mold |
NMT300cfu/g |
Conform |
USP<61> |
|
E.Coli |
Not Detected in(g) 10 |
Not Detected |
USP<61> |
|
Salmonella |
Not Detected in(g) 25 |
Not Detected |
USP<61> |
|
Packing and Storage |
25kg net. Polyethylene bag with cardboard drum; Store in tight, light-resistant containers; Avoid exposure to direct sunlight, moisture, and excessive heat. |
||
|
Conclusion |
The product conforms with above Specifications. |
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