Active Member
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[China]
Address: 1401 Suite B, HuiXin IBC,No.1 Zhang Ba 1 Road, Hi-tech Development Zone, Xi\'an. China.
Contact name:Closer Meng
Xi 'an Green Spring Technology Co., Ltd |
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| Certificate of Analysis | ||||
| Product Name: | Cytisine | |||
| Botanical Name: | Thermopsis lanceolate
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| Plant Part: | Seed | |||
| Batch Number: | JQHJ20160610 | |||
| Batch Quantity: | 25kgs | |||
| Date: | 2016-06-10 | |||
| Item | Specification | Result | ||
| Assay(HPLC) | ||||
| Cytisine (On anhydrous basis) | ≥98% | 99.2% | ||
| Identification | ||||
| A:IR | IR spectrum corresponds to the reference spectrum | Complies | ||
| B: UV | Absorbance maxima between 200nm and 340nm is 232nm and 305nm
| Complies | ||
| C:HPLC | The retention time of the major peak in the chromatogram of | Complies | ||
| the Assay preparation corresponds to that in the chromatogram | ||||
| of the Standard preparation, as obtained in the Assay.
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| Physical Control | ||||
| Appearance: | Crystalline Powder | Complies | ||
| Color: | Off-White | Complies | ||
| Odor: | Characteristic | Complies | ||
| Melt point: | 154℃~157℃ | 155℃ | ||
| Optical Rotation: | -118°~-125° | -120° | ||
| Bulk Density: | 40-60g/100ml | Complies | ||
| Mesh Size: | 80 mesh | Complies | ||
| Loss On Drying: | ≤1% | 0.8% | ||
| Chemical Control | ||||
| Residue on ignition: | ≤0.1% | 0.08% | ||
| Total Heavy Metals: | ≤10PPM | Complies | ||
| Arsenic: | ≤2PPM | Complies | ||
| Pb: | ≤2PPM | Complies | ||
| Related Substances | ||||
| N-Methylcytisine | ≤0.5% | Complies | ||
| N-Formylcytisine | ≤0.5% | Complies | ||
| Individual unspecified impurity | ≤0.3% | Complies | ||
| Total of other impurities | ≤1.5% | Complies | ||
| Residue solvent | ||||
| Methanol: | ≤3000ppm
| Complies | ||
| Chloroform: | ≤60ppm | Complies | ||
| Acetone: | ≤5000ppm | Complies | ||
| Microbiological Control | ||||
| Total Plate Count: | <1000CFU/gm | Complies | ||
| Yeast&Mold: | <100CFU/gm | Complies | ||
| Salmonella: | Negative | Complies | ||
| E.Coli: | Negative | Complies | ||
| Staphylococcus: | Negative | Complies | ||
| Storage: |  Closed keep in cool,dry and dark place ;keep from heat and strong
light | |||
| Shelf life: | 12 Months | |||
| The product Complies with the requirements | ||||
| QA Manager:Jiao Yuejuan | QC Manager:Jiao Bei | Analyst:Ma Haijuan | ||
