| 查看: 1397 | 回复: 6 | ||
[求助]
看不懂的系统适用性案例-EP8.0 头孢他啶 已有2人参与
|
|
EP8.0 头孢他啶原料药质量标准中杂质F（即吡啶）的含量测定方法如下： Impurity F. Liquid chromatography (2.2.29). Prepare the solutions immediately before use. Phosphate buffer solution. Prepare a 10 per cent V/V solution of phosphate buffer solution pH 7.0 R4. Test solution. Dissolve 0.500 g of the substance to be examined in phosphate buffer solution and dilute to 100.0 mL with the same solution.（供试品浓度为5mg/ml） Reference solution (a). Dissolve 1.00 g of pyridine R in water R and dilute to 100.0 mL with the same solvent. Dilute 5.0 mL of the solution to 200.0 mL with water R. Dilute 1.0 mL of this solution to 100.0 mL with phosphate buffer solution.（对照品浓度为2.5ug/ml，限度为500ppm） Reference solution (b). Dilute 1 mL of the test solution to 200 mL with phosphate buffer solution. To 1 mL of this solution add 20 mL of reference solution (a) and dilute to 200 mL with phosphate buffer solution.（原料药浓度为0.125ug/ml（相当于供试品浓度的0.0025%），吡啶浓度为0.25ug/ml（相当于限度浓度的10%）。为什么溶液B中原料药的浓度不是供试品一样，即供试品为5mg/ml，吡啶为2.5ug/ml？这样设计是出于什么考虑？） Column: – size: l = 0.25 m, Ø = 4.6 mm; – stationary phase: octadecylsilyl silica gel for chromatography R (5 μm). Mobile phase: mix 8 volumes of a 28.8 g/L solution of ammonium dihydrogen phosphate R previously adjusted to pH 7.0 with ammonia R, 24 volumes of acetonitrile R and 68 volumes of water R. Flow rate: 1.0 mL/min. Detection: spectrophotometer at 255 nm. Injection: 20 μL. Run time: 10 min. System suitability: reference solution (b): – resolution: minimum 7.0 between the peaks due to ceftazidime and impurity F. Limit: – impurity F: not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (500 ppm). |
回复此楼» 猜你喜欢
医药口服制剂辅料应用
已经有0人回复
-
全新推出Tguide®靶向递送方案，突破99% T细胞转染效率
已经有1人回复
-
药理学论文润色/翻译怎么收费?
已经有255人回复
-
Mal-LN29-LNP-mRNA 试剂盒：自带Mal基团，一盒实现抗体筛选与体内靶向验证
已经有0人回复
-
自由偶联 | 脾脏靶向：抗体偶联空载LNP试剂盒
已经有0人回复
-
SM-102 试剂盒，告别纳米制备仪！
已经有0人回复
-
2026年辅料登记预告
已经有1人回复
-
SPguide®：小鼠体内脾脏转染的一键解决方案
已经有0人回复
-
高效肺靶向RNA转染，加速肺部RNA药物开发
已经有2人回复
-
二糖的糖脂，合成后sephadex LH-20分离不出来，求助
已经有1人回复
veritas_xmu
铁杆木虫 (著名写手)
- 应助: 9 (幼儿园)
- 贵宾: 0.03
- 金币: 1104.3
- 红花: 14
- 帖子: 1070
- 在线: 482.4小时
- 虫号: 1341539
- 注册: 2011-07-09
- 性别: GG
- 专业: 药物分析
2楼2016-01-11 21:44:05
zongyuan
捐助贵宾 (知名作家)
- DRDEPI: 4
- 应助: 304 (大学生)
- 金币: 4637.7
- 散金: 2225
- 红花: 61
- 帖子: 8282
- 在线: 823小时
- 虫号: 766948
- 注册: 2009-05-10
- 性别: GG
- 专业: 药物分析
3楼2016-01-11 21:47:19
4楼2016-01-12 08:05:28
5楼2016-01-12 08:05:47
6楼2016-01-12 10:05:38
7楼2016-01-13 17:22:20