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質檢報告單——CERTIFICATE OF ANALYSIS |
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產品名稱 |
羅紅霉素 |
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產品批號 |
20230909 |
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Product Name |
Roxithromycin |
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Batch No. |
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批次數量 |
1321.2KG |
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生產日期 |
2023-09-14 |
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Quantity |
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Man. Date |
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包裝規格 |
25KG/紙桶/Drum |
檢測日期 |
2023-09-24 |
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Packaging |
Test Date |
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有效日期 |
2025-09-13 |
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報告日期 |
2023-09-27 |
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Expiry Date |
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Report Date |
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檢驗項目 |
檢驗指標 |
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檢驗結果 |
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Test Items |
Standard |
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Test Results |
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外觀 |
白色或類白色結晶性粉末 |
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符合規定 |
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Appearance |
White or off-white crystalline powder |
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Complies |
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溶解性 |
符合規定 |
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符合規定 |
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Solubility |
Complies |
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Complies |
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鑒別 |
符合規定 |
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符合規定 |
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Identification |
Complies |
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Complies |
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溶液外觀 |
澄清無色 |
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符合規定 |
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Solution of appearance |
Clear and colourless |
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Complies |
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比旋度 |
-93° ~ -96° |
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-94° |
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Specific rotation |
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雜質 A Impurity A≤0.5% |
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0.14% |
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雜質 B Impurity B≤0.5% |
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ND |
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雜質 C Impurity C≤0.5% |
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0.15% |
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雜質 D Impurity D≤0.5% |
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0.079% |
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有關物質 HPLC |
雜質 E Impurity E≤0.5% |
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ND |
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雜質 F Impurity F≤0.5% |
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0.17% |
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Related substances |
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雜質 G Impurity G≤1.0% |
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0.088% |
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雜質 H Impurity H≤0.5% |
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0.095% |
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雜質 I Impurity I≤0.5% |
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0.36% |
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雜質 J Impurity J≤0.5% |
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0.11% |
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總雜質 Total impurities≤3.0% |
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1.4% |
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甲醇 Methanol≤3000ppm |
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222ppm |
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丙酮 Acetone≤5000ppm |
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21ppm |
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殘留溶劑 |
Thiethy lamine≤320ppm |
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ND |
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Residual solvent |
二氯甲烷 Methylene chloride≤600ppm |
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ND |
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N,N-二甲基甲酰胺 N,N-Dimethylformamide≤880ppm |
ND |
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醋酸 Acetic Acid≤5000ppm |
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54ppm |
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水分 |
≤3.0% |
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2.1% |
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Water |
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硫酸灰分 |
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≤0.1% |
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0.06% |
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Sulphated ash |
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含量（無水物） |
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96.0~102% |
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97.5% |
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Assay（Anhydrous） |
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結論 |
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本品符合 EP10.0 質量標準 |
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Conclusion |
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Complies with EP10.0 standard |
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Tester(化驗)：Zhangmin |
Re-tester(復核)：Wanghong |
Director(主管)：Liliang |
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