品名
Product Name |
盐酸环丙沙星CIPRCFLOXACINRYDRCCHLORIDE |
批号
Batch NO. |
070723 |
生产日期Manufacture date |
07/07/23 |
报告日期Cdrtificate date |
07/07/25 |
包装规格Package |
25kg/桶 |
数量Quantity |
500kg |
检验项目及结果 |
检验项目Itcms |
检验标准Speciffcations |
结果Results |
性状Charactors |
白色或微黄色结晶性粉末
White or light-yellow orystalline powder |
微黄色结晶性粉末
Liget-yellow orystalline powder |
鉴别
Identincation |
符合规定
Mcet the requirementss |
符合规定
Meet the requlrements |
硫酸盐
Sulfate |
≤0.04%
Not more than 0.04% |
﹤0.04% |
氟喹啉酸
Pluotoquinolonte acid |
符合规定
Mcet the requirementss |
符合规定
Mcet the requirementss |
PH值
Acidity |
3.0—4.5
Between 3.0 and 4.5 |
3.8 |
其它任何单个杂质
Any other individual impurity |
≤0.2%
Nor more than 0.2% |
﹤0.1% |
总杂质
Chiomatographle purity |
≤0.5%
Nor more than 0.5% |
0.23% |
环丙沙星乙酰胺类似物Ciprofioxacin ethylenediamine analog |
≤0.2%
Nor more than 0.2% |
0.07% |
水分Water |
4.7%~6.7%
Between 4.7% and 6.7% |
5.5% |
炽灼残渣
Residue on ignirion |
≤0.1%
Nor more than 0.2% |
0.06% |
重金属
Heavy metais |
≤0.002%
Nor more than 0.002% |
﹤0.002% |
含量(以干燥品计)
ASSEY(on the dried basis) |
98.0%~102.0%(C17H18FN3O3HCL)
Between 98.0% and 102.0% |
100.1% |
结论
Conclusion |
本品符合《美国药典》29版Mecl the requirements of USP 29 |
