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CERTIFICATE OF ANALYSIS
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Product Name |
Melatonin (N-Acetyl-5-Methoxytryptamine) |
Batch No. |
20201201 |
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|
CAS No. |
73-31-4 |
Formula |
C13H16N2O2 |
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|
MFG. Date |
Dec 10,2020 |
Exp Date |
Dec 09,2022 |
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|
Quantity |
300kgs |
Ref. Standard |
Enterprise Standard |
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ITEMS |
METHOD |
SPECIFICATIONS |
RESULTS |
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|
Description |
Visual Inspection |
Off-White to white crystalline powder |
Conforms |
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Identification |
IR |
Conforms to reference |
Conforms |
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Chromatographic |
TLC |
No secondary spot and identical Rf to reference |
Conforms |
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|
Assay |
HPLC Melatonin HPLC Impurities Peak E |
≥99.0% Total≤1.0% Absent |
99.5% Not Detected Absent |
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Sulphated Ash |
USP |
≤0.1% |
0.04% |
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|
Heavy Metals |
USP |
≤10ppm |
＜10ppm |
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Arsenic |
USP |
≤1ppm |
＜1ppm |
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Loss on Drying |
USP |
≤0.2% |
0.05% |
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Melting Point |
USP |
117～119oC |
117～118 oC |
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Bulk Density |
USP |
g/ml |
0.44g/ml |
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Tap Density |
USP |
g/ml |
0.62g/ml |
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Particle Size |
USP |
100% through 40 mesh |
Conforms |
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Residual Solvents |
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Ethyl Acetate |
USP |
Absent |
Absent |
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Acetic Acid |
USP |
Absent |
Absent |
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Ethanol |
USP |
≤50ppm |
200ppm |
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Microbiological Analysis |
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Total plate counts |
USP |
≤1000cfu/g |
＜1000cfu/g |
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Yeast and Mold |
USP |
≤100cfu/g |
＜100cfu/g |
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|
E.Coli |
USP |
Negative |
Negative |
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Staphylococcus |
USP |
Negative |
Negative |
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|
salmonella |
USP |
Negative |
Negative |
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