产品名称(Produce Name):铁皮石斛提取物 Dendrobium candidum P.E)
植物名称(Botanical Name):铁皮石斛 Dendrobium candidum
提取溶剂(Solvents Used): ** or Ethanol
使用部位(Used Part): stem
检测项目Items |
标准Standards |
检测结果Results |
检测方法Method |
理化分析Physical and chemical analysis: |
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性状Description |
类白色粉末White powder |
符合规定Qualified |
Visual |
规格(粗多糖,以葡萄糖计)Specifications (Crude polysaccharide, measured by glucose) |
≥45% |
45.3%(UV) |
UV |
甘露糖seminose(外检) |
/ |
16%(HPLC) |
HPLC |
粒径Mesh Size |
80目95%pass 80mesh |
符合规定Qualified |
ChP2015 |
Identification |
(+) |
Positive |
TLC |
总灰分Ash Content |
≤5.0% |
4.95% |
ChP2015 |
干燥失重Loss on Drying |
≤5.0% |
4.06% |
ChP2015 |
松密度Bulk density |
/ |
31g/100ml |
ICH指导原则-Q4B Annex13 |
紧密度Tap density |
/ |
56g/100ml |
ICH指导原则-Q4B Annex13 |
残留物分析Residue analysis: |
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铅(Pb) |
≤2.0mg/kg |
1.05mg/kg |
ChP2015 |
砷(As) |
≤1.0mg/kg |
0.63mg/kg |
ChP2015 |
汞(Hg) |
≤0.3mg/kg |
未检出 Not detected |
ChP2015 |
六六六 benzex |
Meet USP Requirements |
未检出 Not detected |
USP34 <561> |
滴滴涕 DDT |
Meet USP Requirements |
未检出 Not detected |
USP34 <561> |
微生物Microbiological: |
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细菌总数Total Plate Count |
≤1000 cfu/g |
120 cfu/g |
GB 4789.2-2016 |
霉菌及酵母菌Yeast&Mold |
≤100 cfu/g |
50 cfu/g |
GB 4789.15-2016 |
大肠杆菌E.coil |
≤10 cfu/g |
未检出 Not detected |
GB 4789.3-2016 |
金黄色葡萄球菌 Staphylococcus aureus |
不得检出Not to be detected |
未检出 Not detected |
GB 4789.10-2016 |
沙门氏菌salmonella |
不得检出Not to be detected |
未检出 Not detected |
GB 4789.4-2016 |
一般资料General Information: |
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包装Packing |
外包装为纸板桶,内包装为双层塑料袋,25kg纸板桶尺寸为直径35cm,高51cm; Packed in paper-drums and two plastic-bags inside. N.W:25kgs .I.D.35×H51cm; |
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存储条件Storage |
请存放在阴凉干燥的地方,远离强光和热源。 Keep in cool & dry place. Keep away from strong light and heat. |
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保质期Shelf life |
原包装状态保质期24个月。 24 months under the conditions above and in its original packaging. |
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结论Conclusion |
合格Conform to specification. |