XI'AN NATURAL -FIELD BIO-TECHQUE CO.,LTD
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Botanic Origin:Polygonum cuspidatumSieb. Et Zucc.
Used Part:Root and stem
1. Specification:
Appearance: White fine powder
Active ingredient: Polydatin
Assay:
polydatin | 8% , by HPLC |
polydatin | 98%, by HPLC |
Particle size: 80 Mesh
Total Heavy Metals : ≤10ppm
Arsenic≤0.5ppm
Cadmium≤0.5ppm
Chromium≤2.0ppm
Pb≤2.0ppm
Total Mercury≤0.5ppm
Loss on Drying: ≤5.0%
2. Microbiological Control
Total plate count: ≤1000cfu/g
Yeast & Molds: ≤100 cfu/g
E.coli. Absence
Salmonella species: Absence
Staphylococcus: Absence
3. Functions:
With the pharmacological functions such as antisepsis, oxidation resistance. Protecting against heart disease, cancer, platelet aggregation, vessel flaccidity, decreasing blood fat and resisting mutagenesis, etc
4. Packing and storage:
Storage: Store in cool & dry place, Keep away from strong light and heat.
Shelf life: 24 Months when properly stored.
Packing: Packed in paper-drums and two plastic-bags inside.25kg/drum
Product name: | POLYDATIN | ||
CAS No: | 65914-17-2 | Used part: | root |
Plant Latin name: | Polygonum cuspidatumSieb. Et Zucc. | Chemical Name: | 3,4'-5-Trihydroxystilbene-3-beta-D-glucopyranoside |
Batch Number: | NF-20130609 | Manu. Date: | Jan. 09, 2013 |
Batch Size | 100KGS | Expiration Date: | Jan. 08, 2015 |
Net Weight: | 50KGS | Report Date | Jan. 12, 2013 |
Storage Condition: | Preserve in tight containers at controlled room temperature | ||
Item | Specification | Result | Method |
Identification | TLC | Conforms | |
HPLC | Conforms | ||
Assay | Polydatin ≥98.00% | 98.83% | HPLC |
Organoleptic | |||
Appearance | Fine Powder | Conforms | Visual |
Color | White or off white | Conforms | Visual |
Odor | Characteristic | Conforms | Organoleptic |
Taste | Characteristic | Conforms | Organoleptic |
Drying Method | Vacuum drying | Conforms | |
Excipient | None | Conforms | |
Physical Characteristics | |||
Particle Size | 100%Through 80 mesh | Conforms | GB5507-85 |
Loss on Drying | ≤2.0% | 0.63% | GB/T12531-1990 |
Ash content | ≤1.0% | 0.37% | AOAC942.05,17th |
Bulk density | 48-52g/100ml | Conforms | |
Solubility | Soluble in water and ethanol | Conforms | |
Heavy metals | |||
Total Heavy Metals | ≤10ppm | Conforms | CP2000 IXE |
Arsenic | ≤0.5ppm | Conforms | GB/T5009.11-1996 |
Cadmium | ≤0.5ppm | Conforms | GB/T5009.11-1996 |
Chromium | ≤2.0ppm | Conforms | GB/T5009.11-1996 |
Pb | ≤2.0ppm | Conforms | GB/T5009.12-1996 |
Total Mercury | ≤0.5ppm | Conforms | GB/T5009.11-1996 |
Pesticides | |||
666 | ≤0.1ppm | Conforms | USP |
DDT | ≤0.1ppm | Conforms | USP |
Mycotoxines | |||
Aflatoxins | Negative | Negative | |
Residual Solvents | Meets the requirements of ICH of ICH | Conform | |
Ethyl Acetate | Negative | Negative | Enterprise Standard |
Acetone | Negative | Negative | Enterprise Standard |
Ethanol | ≤5000ppm | 963ppm | Enterprise Standard |
Acetic acid | Negative | Negative | Enterprise Standard |
Microbiological Tests | |||
Total Plate Count | ≤1000cfu/g | 133cfu/g | AOAC990.12,16 th |
Total Yeast & Mold | ≤100cfu/g | 26cfu/g | FDA(BAM)Chapter18.8th Ed |
Total Coliforms | Negative | Negative | AOAC |
E.Coli | Negative | Negative | AOAC975.55,16 th |
Salmonella | Negative | Negative | FDA(BAM)Chapter5.8 th Ed |
Staphylococcus | Negative | Negative | AOAC |
Pseudomonas | Negative | Negative | AOAC |
Non-Irradiated, Non-GMO, Non-Allergen | |||
Conclusion: | Conform to In-house standard | ||
Tested by: | Ms. Meng | Approved by: | Mr. wang |