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化验报告单
ANALYSIS CERTIFICATE
生产日期PRO.DATE:2023.07.19 失效日期EXP.DATE:2025.07.19
品名 Product Name |
Baclofen |
批号Batch No. |
20230708 |
|
数量Quantity |
50kg |
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项目 Items |
标准 Standard |
检验结果 Results |
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外观 Appearance |
白色或类白色粉末 A white or almost white powder |
符合 Complies |
||
鉴别Identification IR-Spectrum HPLC |
Complies with IR |
符合 Complies |
||
The retention time of the Sample solution corresponds to that of the standard solution,as obtained in the assay |
符合 Complies |
|||
水分 Water% |
≤3.0 |
0.17 |
||
炽灼残渣 Residue on ignition % |
≤0.3 |
0.10 |
||
重金属 Heavy metals μg/g |
≤10 |
<10 |
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相关物质 Related compounds % |
Impurity A≤1.0 Other single impurity ≤0.1 Total impurities ≤2.0 |
符合 Complies |
||
有机挥发物 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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包装 Package |
25kg/桶 |
符合 Complies |
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结论 Conclution |
本品符合USP39(非无菌粉) |