盐酸环丙沙星USP30标准原粉原料检测数据报告
质量报告单
CERTIFICATE OF ANALYSIS
|
品 名Product Name |
盐酸环丙沙星 Ciprofloxacin Hydrochloride |
生产批号Lot no |
200503 |
|
包装容器Packing |
纸板桶Fiber Drum |
数量Quantity |
6KG |
|
生产日期MFG. Date |
20200503 |
检验日期 |
20200503 |
|
检验依据 Quality Specification |
USP30版USP30Edition |
有效期EXP.Date |
20220502 |
|
检验项目Test Items |
检验指标Specification |
检验结果Test Results |
|
|
外观Description |
白色或类白色结晶性粉末 White or Off-White Crystalline Powder |
CONFORM |
|
|
溶解度Solubility |
Meets the requirements |
CONFORM |
|
|
溶液颜色Colour of solution |
Meets the requirements |
CONFORM |
|
|
氟喹诺酮酸 Fluoroquinoloic Acid（%） |
≤0.2 |
<0.2 |
|
|
硫酸盐Sulfate（%） |
≤0.04 |
<0.04% |
|
|
PH (lin40) |
3.0~4.5 |
3.7 |
|
|
水分Water by K.F.(%) |
4.7~6.7 |
6.0% |
|
|
灼烧残渣 Resudue On Ignition |
≤0.1 |
0.02% |
|
|
重金属Heavy Metals |
≤0.002 |
<0.002 |
|
|
色谱纯度 Chromatographic Purity |
Meets the requirements |
CONFORM |
|
|
单一杂质Single impurity |
≤0.2 |
0.17% |
|
|
其他但以杂质 Any other individual impurities |
≤0.2 |
<0.2% |
|
|
总杂质 Total impurities（%） |
≤0.5 |
0.47% |
|
|
含 量Assay（%） |
98.0~102.0 |
99.3% |
|
|
结 论Conclusion |
检验指标符合USP30版 The Specification conform with USP30 Edition |
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