產(chǎn)品名稱(Produce Name):鐵皮石斛提取物 Dendrobium candidum P.E)
植物名稱(Botanical Name):鐵皮石斛 Dendrobium candidum
提取溶劑(Solvents Used): ** or Ethanol
使用部位(Used Part): stem
檢測(cè)項(xiàng)目Items |
標(biāo)準(zhǔn)Standards |
檢測(cè)結(jié)果Results |
檢測(cè)方法Method |
理化分析Physical and chemical analysis: |
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性狀Description |
類白色粉末White powder |
符合規(guī)定Qualified |
Visual |
規(guī)格(粗多糖,以葡萄糖計(jì))Specifications (Crude polysaccharide, measured by glucose) |
≥45% |
45.3%(UV) |
UV |
甘露糖seminose(外檢) |
/ |
16%(HPLC) |
HPLC |
粒徑Mesh Size |
80目95%pass 80mesh |
符合規(guī)定Qualified |
ChP2015 |
Identification |
(+) |
Positive |
TLC |
總灰分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指導(dǎo)原則-Q4B Annex13 |
緊密度Tap density |
/ |
56g/100ml |
ICH指導(dǎo)原則-Q4B Annex13 |
殘留物分析Residue analysis: |
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鉛(Pb) |
≤2.0mg/kg |
1.05mg/kg |
ChP2015 |
砷(As) |
≤1.0mg/kg |
0.63mg/kg |
ChP2015 |
汞(Hg) |
≤0.3mg/kg |
未檢出 Not detected |
ChP2015 |
六六六 benzex |
Meet USP Requirements |
未檢出 Not detected |
USP34 <561> |
滴滴涕 DDT |
Meet USP Requirements |
未檢出 Not detected |
USP34 <561> |
微生物Microbiological: |
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細(xì)菌總數(shù)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 |
大腸桿菌E.coil |
≤10 cfu/g |
未檢出 Not detected |
GB 4789.3-2016 |
金黃色葡萄球菌 Staphylococcus aureus |
不得檢出Not to be detected |
未檢出 Not detected |
GB 4789.10-2016 |
沙門氏菌salmonella |
不得檢出Not to be detected |
未檢出 Not detected |
GB 4789.4-2016 |
一般資料General Information: |
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包裝Packing |
外包裝為紙板桶,內(nèi)包裝為雙層塑料袋,25kg紙板桶尺寸為直徑35cm,高51cm; Packed in paper-drums and two plastic-bags inside. N.W:25kgs .I.D.35×H51cm; |
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存儲(chǔ)條件Storage |
請(qǐng)存放在陰涼干燥的地方,遠(yuǎn)離強(qiáng)光和熱源。 Keep in cool & dry place. Keep away from strong light and heat. |
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保質(zhì)期Shelf life |
原包裝狀態(tài)保質(zhì)期24個(gè)月。 24 months under the conditions above and in its original packaging. |
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結(jié)論Conclusion |
合格Conform to specification. |