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质检单
品 名 Product Name |
盐酸土霉素 OXYTETRACYCYCLINE HCL |
生产批号 Lot no |
211210 |
生产日期 MFG. Date |
2021.12.10 |
分析日期 |
2021.12.15 |
检验项目 Test Items |
检验指标 Specification |
检验结果 Test Results |
|
形状 Description |
黄色结晶粉末 Yellow crystalline powder |
符合 Complies |
|
鉴别 Identification |
依据BP2007 According to BP2007 |
符合 Complies |
|
PH值 PH Value |
2.3~2.9 Between 2.3 and 2.9 |
2.45 |
|
吸收系数 Absorbance(353nm,ph2.0) |
270~290 Between270~290 |
270.3 |
|
比旋度 Specific optical Rotation |
-188°~ -200° Between -188°~ -200° |
190.3 |
|
重金属 Heavy metals |
不得大于50 Not more than 50 |
符合 Complies |
|
杂质吸收度 Light zbsorbing Impurities |
A(02%),1cm,430nm<0.50 Absorbance at 430nm shall Not be more than 0.50 A(1%,1cm,490nm),0.20 Absorbance at 490nm shall Not be more than 0.20 |
0.34
0.05 |
|
相关物质 Related substances |
杂峰含量应符合规定 Content of impurity peak Meets the requirements |
符合 Complies |
|
硫酸盐灰分 Sulphated ash |
不得大于0.5% Not more than 0.5% |
0.12 |
|
水份Water |
不得大于2.0% Not more than 2.0% |
0.97 |
|
含量(HPLC) (HPCL)Assay |
95.0%~102.0%(按无水物计) Between 95.0% and 102.0% Anhydrous substabce |
96.8 |
|
结论 Conclusion |
本品符合英国药典2007版之规定 This product fulfils bp2007 |