Certificate of Analysis
Product Name |
Phosphatidylserine |
Country of Origin |
China |
Batch No. |
PS-20200619 |
Batch Quantity |
1000KGS |
Manufacturing Date |
Jun 19, 2020 |
Expiry Date |
Jun 18, 2023 |
Sterilization Method |
Heat || NON-IRR |
Kosher || Halal |
Yes |
Items |
Specification |
Result |
Method |
Phosphatidylserine |
Phosphatidylserine≥50% |
51.69% |
HPLC - ELSD |
Phosphatidylethanolamine |
≤10% |
7.85% |
HPLC - ELSD |
Phosphatidylinositol |
≤10% |
3.21% |
HPLC - ELSD |
Phosphatidylcholine |
≤12% |
9.01% |
HPLC - ELSD |
Identification |
Correspond to standard |
Conform |
TLC || USP<201> |
Physical Characteristics |
|||
Appearance |
Light yellow Powder |
Light yellow Powder |
Organoleptic |
Particle Size |
NLT 95% Through 80 mesh |
99.32% |
Analytical sieving || USP <786> |
Peroxide value |
≤10meq/KG |
Conform |
USP <34> |
Loss on Drying |
NMT 2.00% |
1.53% |
USP <731> |
Total Ash |
NMT 2.00% |
0.97% |
USP <561> |
Chemical Characteristics |
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Heavy Metals (as Pb) |
NMT 10ppm |
Conform |
USP <231> Method II |
Arsenic (As) |
NMT 2ppm |
Conform |
ICP-MS |
Lead (Pb) |
NMT 2ppm |
Conform |
ICP-MS |
Cadmium (Cd) |
NMT 1ppm |
Conform |
ICP-MS |
Microbiological Characteristics |
|||
Total Plate Count |
NMT1000cfu/g |
Conform |
USP<61> |
Yeast & Mold |
NMT100cfu/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. |
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Conclusion |
The product conforms with above Specifications. |