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化驗報告單
ANALYSIS CERTIFICATE
生產日期PRO.DATE:2023.07.19 失效日期EXP.DATE:2025.07.19
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品名 Product Name |
Baclofen |
批號Batch No. |
20230708 |
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數量Quantity |
50kg |
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項目 Items |
標準 Standard |
檢驗結果 Results |
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外觀 Appearance |
白色或類白色粉末 A white or almost white powder |
符合 Complies |
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鑒別Identification IR-Spectrum HPLC |
Complies with IR |
符合 Complies |
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The retention time of the Sample solution corresponds to that of the standard solution，as obtained in the assay |
符合 Complies |
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水分 Water% |
≤3.0 |
0.17 |
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熾灼殘渣 Residue on ignition % |
≤0.3 |
0.10 |
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重金屬 Heavy metals μg/g |
≤10 |
＜10 |
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相關物質 Related compounds % |
Impurity A≤1.0 Other single impurity ≤0.1 Total impurities ≤2.0 |
符合 Complies |
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有機揮發物 Organic volatile impurities |
Meets the requirements |
符合 Complies |
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含量 Assay % （calculated on the anhydrous basis，by HPLC） |
98.0%-102.0 |
98.75 |
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包裝 Package |
25kg/桶 |
符合 Complies |
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結論 Conclution |
本品符合USP39（非無菌粉） |
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