日本药典翻译咨询

luckyoo

日本药典中，样品制备中有这样的描述“1mol/L hydrochloric acid TS (3 in 100)”表达的是1mol/L的盐酸吗？还是取1mol/L的盐酸3ml至100ml中？
原文见附件，含量测定项下。谢谢大家！

hongwei2000

luckyoo 发表于 2019-11-14 11:35
你好，原文我粘贴上了，本来想上传JP原文的，但不知道在哪里上传,粘贴的能看的清吗？谢谢

应该是指用1M盐酸试液稀释为3到100的溶液

hongwei2000

要有上下文

luckyoo

Assay  To an exact volume of Levofloxacin Injection,equivalent  to about  50 mg  of levofloxacin(C18H20FN3O4),add diluted 1 mol/L hydrochloric acid TS (3 in 100) to make exactly 50 mL. Pipet 5 mL of this solution, add diluted 1 mol/L hydrochloric acid TS (3 in 100) to make exactly 100mL, and use this solution as the sample solution. Separately,weigh accurately about 50 mg of levofloxacin hydrate for assay (separately determine the water <2.48> in the same manner as Levofloxacin Hydrate), and dissolve in diluted 1 mol/L hydrochloric acid TS (3 in 100) to make exactly 50mL. Pipet 5 mL of this solution, add diluted 1 mol/L hydrochloric acid TS (3 in 100) to make exactly 100mL, and use this solution as the standard solution. Perform the test with exactly 10 mL each of the sample solution and standard solution as directed under Liquid Chromatography <2.01> according to the following conditions, and determine the peak areas, AT and AS, of levofloxacin in each solution.

luckyoo

luckyoo 发表于 2019-11-14 11:31
Assay  To an exact volume of Levofloxacin Injection,equivalent  to about  50 mg  of levofloxacin(C18 ...

含量测定项下的全文

luckyoo

hongwei2000 发表于 2019-11-14 11:18
要有上下文

你好，原文我粘贴上了，本来想上传JP原文的，但不知道在哪里上传,粘贴的能看的清吗？谢谢

lirandapk

同意楼上看法。

luckyoo

hongwei2000 发表于 2019-11-14 13:08
应该是指用1M盐酸试液稀释为3到100的溶液

好的，非常感谢！我也觉得是这样

ryuki88

你把日语原文发给我吧，我帮你确认下吧！

luckyoo

ryuki88 发表于 2019-11-16 22:28
你把日语原文发给我吧，我帮你确认下吧！

你好，原文已经附上去了，谢谢

ryuki88

你的附件我看不到，自己从PMDA官网上查看了下
那段话的意思应该是，取稀释过的1mol/L盐酸，具体的稀释方法是
取1mol/L的盐酸3ml加水至100ml

另，我曾经负责过这个产品的申报，PMDA的照会很难对付
祝你好运

luckyoo

ryuki88 发表于 2019-11-28 08:00
你的附件我看不到，自己从PMDA官网上查看了下
那段话的意思应该是，取稀释过的1mol/L盐酸，具体的稀释方法 ...

哈哈，谢谢啊，会努力的！

小金库

感谢分享。