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質(zhì)檢報(bào)告單——CERTIFICATE OF ANALYSIS |
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產(chǎn)品名稱 Product Name |
硫酸奈替米星 Netilmicin sulfate |
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CAS NO. |
56391-57-2 |
產(chǎn)品批號(hào) Batch No. |
23-06-13 |
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批次數(shù)量 Quantity |
76KG |
生產(chǎn)日期 Man. Date |
2023-06-17 |
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包裝規(guī)格 Packaging |
10KG/鋁聽(tīng)/Tin |
檢測(cè)日期 Test Date |
2023-06-27 |
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有效日期 Expiry Date |
2026-06-12 |
報(bào)告日期 Report Date |
2023-08-03 |
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檢驗(yàn)項(xiàng)目 Test Items |
檢驗(yàn)指標(biāo) Standard |
檢驗(yàn)結(jié)果 Test Results |
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性狀 Characteristics |
為白色或微黃色粉末 White or yellowish powder |
白色粉末 White powder |
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鑒別 Identification |
A、B 符合規(guī)定 Complies |
符合規(guī)定 Complies |
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溶液的澄清度 Clarity of solution |
澄清 Clear |
＜1# |
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比旋度 Specific rotation |
+88.0°~ +96.0° |
+91° |
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PH |
3.5~5.5 |
4.4 |
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干燥失重 Loss on drying |
≤15.0% |
6.6% |
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熾灼殘?jiān)?/p> Residue on ignition |
≤1.0% |
＜0.1% |
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有關(guān)物質(zhì) Related substances |
任何單個(gè)雜質(zhì) Any individual impurity≤1.0% 總雜 Total impurities≤5.0% |
＜1% 1% |
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細(xì)菌內(nèi)毒素 Bacterial endotoxins |
≤0.5EU/mg |
＜0.5EU/mg |
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微生物限度 Microbial limits |
需氧菌總數(shù) Total aerobic bacteria≤1000CFU/g霉菌和酵母菌 Moulds and yeasts ≤100CFU/g大腸埃希菌 Escherichia Coli 不得檢出 Negative |
＜10CFU/g ＜10CFU/g ND |
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含量 Assay |
≥595μg/mg(按干燥品,on dry basis) |
644μg/mg |
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結(jié)論 Conclusion |
本品符合 USP42 質(zhì)量標(biāo)準(zhǔn) Complies with USP42 standard |
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