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质量报告单
CERTIFICATE OF ANALYSIS
品 名Product Name |
环丙沙星 Ciprofloxacin |
生产批号Lot no |
20220709 |
包装容器Packing |
纸板桶Fiber Drum |
数量Quantity |
870KG |
生产日期MFG. Date |
2022.07.09 |
检验日期 |
2022.07.09 |
检验依据 Quality Specification |
USP35版USP35Edition |
有效期EXP.Date |
2024.07.08 |
检验项目Test Items |
检验指标Specification |
检验结果Test Results |
|
外观Description |
白色至微黄色结晶性性粉末 White or Off-White Crystalline Powder |
类白色 Almost |
|
硫酸盐 sulfate |
≤0.04% |
<0.04% |
|
溶液颜色Colour of solution |
Meets the requirements |
CONFORM |
|
水分Water by K.F.(%) |
≤1.0% |
0.5% |
|
灼烧残渣 Resudue On Ignition |
≤0.1 |
0.02% |
|
重金属Heavy Metals |
≤0.002 |
<0.002 |
|
单一杂质Single impurity |
≤0.2 |
0.17% |
|
总杂质 Total impurities(%) |
≤0.5 |
0.4% |
|
含 量Assay(%) |
98.0~102.0 |
98.6% |
|
结 论Conclusion |
检验指标符合企业标准 The Specification conform with enterprise standard |