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質量報告單
CERTIFICATE OF ANALYSIS
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品 名 Product Name |
鹽酸金霉素 Chlortetracycline HCl |
數(shù) 量 Quantity |
200kg |
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批 號 Batch No |
20240409 |
包 裝 Packing |
25kg/drum |
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生產(chǎn)日期 MFG. Date |
2024.04.22 |
有 效 期 Exp. Date |
2026.04.23 |
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檢驗依據(jù) Pef. standard |
英國藥典2000 |
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檢驗項目 Test Items |
檢驗指標 Specification |
檢驗結果 Test Results |
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性狀Character |
黃色粉末Yellow powder |
通過Approved |
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鑒別Identification |
滿足要求Meets the requirements |
通過Approved |
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比旋度Spec rotation |
-235o～-250o |
-242o |
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酸度PH value |
2.3～3.3 |
2.6 |
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吸光度(E05%1cm) |
≤0.40(460nm) |
0.277 |
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干燥失重Loss on drying |
≤2.0% |
0.73% |
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硫酸灰分Sulphated Ash |
≤0.5% |
0.1% |
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重金屬Heavy metals |
≤50ppm |
通過Approved |
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有關雜質Related Substances |
滿足要求 Meets the requirements |
通過Approved |
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鹽酸金霉素CTC.HCl |
≥89.5%(HPLC) |
89.70% |
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鹽酸四環(huán)素TC.HCl |
≤8.0%(HPLC) |
5.53% |
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鹽酸差向金霉素 4Epl-CTC.HCl |
≤4.0%(HPLC) |
2.25% |
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鹽酸四環(huán)素加鹽酸金霉素TC.HCl+CTC.HCl |
94.5～102%(HPLC) |
95.23% |
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檢驗結論Conclusion |
合格 Qualified |
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