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質檢報告單——CERTIFICATE OF ANALYSIS |
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產品名稱 Product Name |
鹽酸胺碘酮 Amiodarone hydrochloride |
產品批號 Batch No. |
231011 |
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批次數量 Quantity |
300KG |
生產日期 Man. Date |
2023-10-13 |
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包裝規格 Packaging |
25KG/紙桶/Drum |
檢測日期 Test Date |
2023-10-20 |
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有效日期 Expiry Date |
2025-10-12 |
報告日期 Report Date |
2023-10-21 |
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檢驗項目 Test Items |
檢驗指標 Standard |
檢驗結果 Test Results |
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性狀 Characteristics |
為白色或類白色結晶性粉末 White or off-white crystalline powder |
符合規定 Complies |
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鑒別 Identification |
A、B 符合規定 Complies |
符合規定 Complies |
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溶液 Solution |
符合規定 Complies |
符合規定 Complies |
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熔點 Melting point |
159~163℃ |
159~160.4℃ |
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PH |
3.2~3.8 |
3.58 |
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有關物質 Related substances |
雜質 Impurity H ≤0.02% 單個雜質 Individual impurity ≤0.2%總雜質 Total impurities ≤0.5% |
0.02% 0.08% 0.31% |
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碘化物 Iodides |
≤150ppm |
＜150ppm |
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重金屬 Heavy metals |
≤20ppm |
＜20ppm |
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干燥失重 Loss on drying |
≤0.5% |
0.07% |
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硫酸灰分 Sulphated ash |
≤0.1% |
0.02% |
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含量 Assay |
98.5~101.0% |
99.8% |
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結論 Conclusion |
本品符合 EP9.0 質量標準。 Complies with EP9.0 standard. |
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