| 查看: 541 | 回复: 5 | |||
lcb19700525铁杆木虫 (正式写手)
|
[求助]
求助14C尿素国外质量标准 已有1人参与
|
| 求助14C尿素国外质量标准 |
回复此楼» 猜你喜欢
请教酰胺缩合反应
已经有5人回复
-
一志愿大连理工制药工程专硕086002，本科211，总分342
已经有0人回复
-
药物学论文润色/翻译怎么收费?
已经有241人回复
-
制药工程专业招收调剂，要求过国家线
已经有0人回复
-
五邑大学药物化学生物学团队-李兰清课题组招收调剂学生
已经有0人回复
-
求蛋白推荐，用于实验教学中蛋白药物的表达
已经有0人回复
-
求蛋白推荐，用于实验教学中蛋白药物的表达
已经有0人回复
-
求蛋白推荐，用于实验教学中蛋白药物的表达
已经有2人回复
-
342一志愿大工制药专硕，本科211，求调剂
已经有2人回复
-
可能上不了岸？有条件的可以考虑其他出路
已经有0人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- 求助14C尿素国外质量标准
已经有2人回复
痴夷子皮
版主 (文坛精英)
老痞
- DRDEPI: 8
- 应助: 2016 (讲师)
- 贵宾: 5.368
- 金币: 54487.3
- 散金: 41688
- 红花: 303
- 沙发: 1206
- 帖子: 32611
- 在线: 4303.7小时
- 虫号: 674536
- 注册: 2008-12-14
- 性别: GG
- 专业: 无神论
- 管辖: 人文社科
【答案】应助回帖
感谢参与，应助指数 +1
|
没有原料的 Urea C 14 Capsules » Urea C 14 Capsules contain 14CH4N2O in which a portion of the molecules are labeled with radioactive 14C to provide 0.04 MBq (or 1 µCi) of radioactivity per capsule. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 14C expressed as MBq (or µCi). Packaging and storage— Preserve in tight containers, and store at controlled room temperature. Expiration date— The expiration date is not later than two years from the date of manufacture. Labeling— Label it to include the following: the amount of 14C, expressed in MBq (or µCi) per Capsule at the time of calibration; the expiration date; the total radioactivity per container; and the statement, “Caution—Radioactive material.” Radionuclide identification 821— A solution of 1 or more Capsules in 1 N hydrochloric acid when tested using a liquid scintillation counter produces beta emission having a 49 keV mean and a 156 keV max. Dissolution 711— Medium: simulated gastric fluid TS; 500 mL. Apparatus 1: 50 rpm. Time: 10 minutes. Procedure— Determine the background levels of 14C with a 1-mL portion of the solution under test using a liquid scintillation counter. Tolerances: not less than 80% (Q) of the labeled amount of 14C is dissolved in 10 minutes. Uniformity of dosage units 905: meet the requirements. Radionuclidic purity 821— Determine the radionuclidic purity of a solution of 1 or more Capsules in water using a liquid scintillation counter: not less than 99.9% of the radioactivity is present as C 14. Radiochemical purity— Adsorbent: 0.25-mm layer of chromatographic cellulose. Test solution— Open 2 Capsules and place them in a suitable container, add 8 mL of methanol, and mix. Reference solution: 40 mg of urea per mL, in water. Application volume: 20 µL of the Test solution and 4 µL of the Reference solution. Developing solvent system: n-butanol saturated with water. Procedure— Proceed as directed for Thin-Layer Chromatography under Chromatography 621. Locate the spots on the plate by spraying with Ehrlich's reagent. Determine the radioactivity distribution with a suitable radiation detector (see Radioactivity 821), and obtain the RF value: the RF value of the principal spot from the Test solution corresponds to that obtained from the Reference solution, and the radioactivity of the 14C band is not less than 90% of the total radioactivity. Assay for radioactivity 821— Prepare a solution of 1 or more Capsules in 1 N hydrochloric acid. Using a liquid scintillation counter, determine the radioactivity, in MBq (or mCi) per mL by use of a calibrated system. Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Ravi Ravichandran, Ph.D. Principal Scientific Liaison 1-301-816-8330 (SM42010) Monographs - Small Molecules 4 711 Margareth R.C. Marques, Ph.D. Senior Scientific Liaison 1-301-816-8106 (GCDF2010) General Chapters - Dosage Forms USP35–NF30 Page 2496 Pharmacopeial Forum: Volume No. 27(2) Page 2126 http://www.drugfuture.com/Pharma ... 5nf30s0_m13090.html |
2楼2014-05-15 10:54:16
lcb19700525
铁杆木虫 (正式写手)
- 应助: 0 (幼儿园)
- 金币: 7799.8
- 帖子: 679
- 在线: 90.6小时
- 虫号: 369126
- 注册: 2007-05-12
- 性别: GG
- 专业: 药物学
3楼2014-05-15 13:22:50
4楼2014-05-16 11:10:23
lcb19700525
铁杆木虫 (正式写手)
- 应助: 0 (幼儿园)
- 金币: 7799.8
- 帖子: 679
- 在线: 90.6小时
- 虫号: 369126
- 注册: 2007-05-12
- 性别: GG
- 专业: 药物学
5楼2014-05-19 13:58:33
lcb19700525
铁杆木虫 (正式写手)
- 应助: 0 (幼儿园)
- 金币: 7799.8
- 帖子: 679
- 在线: 90.6小时
- 虫号: 369126
- 注册: 2007-05-12
- 性别: GG
- 专业: 药物学
6楼2014-05-19 13:58:55
