| 查看: 1446 | 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
26年博士申请
已经有20人回复
-
求助 苯磷硫胺JP
已经有0人回复
-
药理学论文润色/翻译怎么收费?
已经有240人回复
-
100金币 阿莫西林克拉维酸钾片BP药典中提到的克拉维酸聚合物具体结构式是啥？
已经有2人回复
-
一志愿苏州大学 生物技术与工程（086001） 初试323分，求调剂
已经有0人回复
-
澳门理工大学人工智能药物发现中心招收2026级博士研究生（申请-考核制）
已经有10人回复
-
三年实验室工作经历，一志愿华中农业大学微生物，总分288求调剂
已经有0人回复
-
膳食补充剂合规性交流
已经有0人回复
-
一志愿浙大药学求调剂
已经有0人回复
-
070700求调剂
已经有1人回复
-
高温高压反应求助
已经有2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
