| 查看: 258 | 回复: 1 | |||
[求助]
丙硫硫胺的质量标准，美国药典，日本药典
|
丙硫硫胺的质量标准，美国药典，日本药典，请详细列出，不胜感激！ |
回复此楼» 猜你喜欢
293求调剂
已经有3人回复
-
335求调剂
已经有5人回复
-
305求调剂
已经有7人回复
-
313求调剂
已经有3人回复
-
310求调剂
已经有12人回复
-
290求调剂
已经有7人回复
-
电气专硕320求调剂
已经有5人回复
-
一志愿西北工业大学289 085602
已经有33人回复
-
一志愿哈工大 085600 277 12材科基求调剂
已经有24人回复
-
268分085602化学工程调剂
已经有28人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- 张钟华院士解析质量标准：一千克究竟有多重
已经有5人回复
- 美国药典里的M和N代表什么单位
已经有8人回复
- 求助日本药典标准翻译
已经有4人回复
- 【祝福】日本文部省日研生、教研生奖学金项目候选人名单公布
已经有9人回复
- 【求助】丙二酸二甲酯和酰氯的反应
已经有21人回复
- 【求助】美国药典中一段原文的翻译问题
已经有4人回复
- 【求助】怎么在美国药典查中药标准？
已经有7人回复
- 【求助】求助Aprepitant 的美国药典质量标准
已经有6人回复
- 【交流】中检所无对照品，制药厂怎么执行中国药典2010版？
已经有29人回复
- 关于美国药典的疑问
已经有4人回复
- 2010年版中国药典编制完成 药品标准进一步提高
已经有15人回复
【答案】应助回帖
★
jiangchunyong(金币+1): 谢谢 2011-08-02 21:46:59
fchg007(金币+10): 2011-08-04 11:02:48
fchg007(金币+5): 2011-09-06 15:33:25
jiangchunyong(金币+1): 谢谢 2011-08-02 21:46:59
fchg007(金币+10): 2011-08-04 11:02:48
fchg007(金币+5): 2011-09-06 15:33:25
|
Assay— Solution A— Prepare a 0.005 M solution of sodium 1-octanesulfonate in dilute glacial acetic acid (1 in 100). Solution B— Prepare a mixture of methanol and acetonitrile (3:2). Mobile phase— Prepare a mixture of Solution A and Solution B (60:40), filter, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621). Internal standard solution— Transfer 2.0 mL of methylbenzoate to a 100-mL volumetric flask, dilute with methanol to volume, and mix. Standard preparation— Dissolve an accurately weighed quantity of USP Thiamine Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 1 mg per mL. Transfer 20.0 mL of this solution to a 50-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix to obtain a Standard preparation having a known concentration of about 400 µg per mL. Assay preparation— Transfer an accurately weighed quantity of about 200 mg of Thiamine Hydrochloride to a 100-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix. Transfer 10.0 mL of this solution to a 50-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix. Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 1 mL per minute. [note—The flow rate may be adjusted as needed to obtain a retention time of about 12 minutes for thiamine hydrochloride. ] Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the thiamine and methylbenzoate peaks is not less than 4.0; the tailing factor for the thiamine peak is not more than 2.0; the column efficiency determined from the thiamine peak is not less than 1500 theoretical plates; and the relative standard deviation for replicate injections is not more than 2.0%. Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the areas of the major peaks. Calculate the quantity, in mg, of C12H17ClN4OS·HCl in the Thiamine Hydrochloride taken by the formula: 0.5C(RU / RS) in which C is the concentration, in µg per mL, of USP Thiamine Hydrochloride RS in the Standard preparation; and RU and RS are the ratios of the peak areas of thiamine to methylbenzoate obtained from the Assay preparation and the Standard preparation, respectively. Auxiliary Information— Please check for your question in the FAQs before contacting USP. Topic/Question Contact Expert Committee Monograph Huy T. Dinh, M.S. Scientific Liaison 1-301-816-8594 (DS2010) Monographs - Dietary Supplements Reference Standards RS Technical Services 1-301-816-8129 rstech@usp.org USP34–NF29 Page 4408 |
2楼2011-08-02 15:41:46
