happyjyl
第1楼2006/06/05
As we were getting the extra ,unseparated , duplet or splitted Peak in our analysis ( done in presence of Chinese people even with using their column and method ) these chromatograms are also exhibiting the unseparated, duplet , splited extra peak at the R.T. 2.42 and 2.54 having the equal basemarking width of only one peak compaired to other peaks of the impurities.
我们在分析时得到了额外的未分离的峰、对峰或裂峰(在中方人员面前当场试验,甚至使用中方人员的色谱柱和分析方法时也是如此),这些色谱图在保留时间为2.42和2.54分钟时也呈现出额外的未分离的峰、对峰和裂峰,与杂质的其它峰相比,这些峰的峰底宽不相上下。
有两个地方不确定:1. basemarking width是不是峰底宽?反正我知道它是峰宽,至于是从什么地方算起的峰宽就不知道了;2.最后一句不是很确定。我猜是在色谱图中出现了很多不明原因的峰,这些峰不同于其它的杂质峰(根据最后一句话的意思,似乎其它的杂质峰的basemarking width都不同,而这些不明原因的峰的basemarking width值都差不多),所以要在中方人员面前用他们的色谱柱和分析方法再做一遍,但结果还是不理想。楼主最好把上下文都帖出来,有了上下文才有翻译的依据。
R.T.=retention time保留时间,后面不跟单位的话一般是指分钟。
我也翻译过几个印度药品的资料,他们的表达确实跟以英语为母语的国家不太一样,还特别喜欢用缩写而不做说明,比如R.T.就是retention time,N.A.就是not available。遇到实在看不懂的可以写邮件请他们详细解释,千万别自己瞎猜。
一抹冰蓝
第2楼2006/06/06
As we were getting the extra ,unseparated , duplet or splitted Peak in our analysis ( done in presence of Chinese people even with using their column and method ) these chromatograms are also exhibiting the unseparated, duplet , splited extra peak at the R.T. 2.42 and 2.54 having the equal basemarking width of only one peak compaired to other peaks of the impurities.
大部赞成happy mm的观点,就是impurities似乎为”混合物“比较妥当;还有后一句觉得不太妥,但是也不知该怎么翻译比较好(印度英语还真让人头大)。
建议楼主给出上下文。
quanchaoli
第3楼2006/06/06
非常感谢斑竹happyjyl wrliao,真是高手!本文的背景是我厂向印度出口6吨利福平原料,但是在质量上有较大分歧,其焦点就是色谱实验操作。现将那篇文章全文贴出。基本上是每句话都让我吃不消。
Dear Sir,
I studied the chromatograms (recd. from Tushar) of analysis of Shenyang Rifampicin, B.No. 20059136 and the observations are as follows.
尊敬的先生:
我分析了沈阳抗生素厂利福平批号为20059136的色谱并得出以下结论。
1) As we were getting the extra ,unseparated , duplet or splitted Peak in our analysis ( done in presence of Chinese people even with using their column and method ) these chromatograms are also exhibiting the unseparated, duplet , splited extra peak at the R.T. 2.42 and 2.54 having the equal basemarking width of only one peak compaired to other peaks of the impurities.
我们在分析时得到了额外的未分离的峰、对峰或裂峰(在中方人员面前当场试验,甚至使用中方人员的色谱柱和分析方法时也是如此),这些色谱图在保留时间为2.42和2.54分钟时也呈现出额外的未分离的峰、对峰和裂峰,与杂质的其它峰相比,这些峰的峰底宽不相上下。
2) All the Chromatograms ( received ) i.e Resolution solution, 3 Standards, Rifampicin Dilute test soln. , Assay solution are chromatographed at the responce of 0.18 Au but only the chromatogram of Test preparation showing impurities is chromatographed at the response 0.44 Au to hide the unseparated problematic impurity peak.
所有色谱,也就是分离溶液,3个标准液,利福平稀释液,分析液色谱的峰响应值为0.18 Au,但只有检测液表明杂质峰响应值为0.44 Au,隐藏了存在问题的未分离杂质峰。
3) We can't understand why the integration parameters are changed for this particular chromatogram. The reason is that , because the peak can not be separated individually in two, acceptable baseline peaks by using the USP method they forcebly ( By manual integration ) marked it in two peaks by minimising the height visuality to show two separate peaks less than 1%
对于这个色谱我们不明白积分参数为什么改变了。原因是因为色谱峰不能分成两个单个的峰,通过USP方法,他们为减小峰的视觉高度,强行将色谱峰标记成两个峰,使其低于1%。
4) As per the chromatograms area Rifa Quinone is not 0.376% but it is 0.808% and problematic peak is 1.187% as considered to a single peak. If it is considered as 2 unseparated peaks the the % will be 0.353% and 0.834%
根据色谱,醌氏利福平峰面积不是0.376%,而是0.808%,如果只考虑是一个峰的话,存在问题的峰是1.187%。如果考虑是两个未分开的峰,那么百分比是0.353%和0.834%。
5) The total impurities ( O.T. Rifa Quinone) calculated upon party's chromatograms is 2.958% ( Lim = NMT 3.5% )
So if at the time of release we will pass the material less than 97% purity what will be the status of the product within expiry
period ?
根据对方的色谱,总杂质含量(O.T.醌氏利福平)为2.958%(Lim=NMT 3.5%)
因此如果在产品出厂时杂质含量就是97%,那么产品在以后(有效期内)又将如何?
So again the matter remains unanswered whether to release these materials taking in to account the calculated Risks in future or Reject these to avoid the Risks of inviting the impurities in our products.
Pralhad
所以问题仍然没有得到解决,在发放产品的时候是否考虑到了产品在将来杂质含量可能会增高的危险。
Pralhad
一抹冰蓝
第5楼2006/06/06
happyjyl
第6楼2006/06/06
the observations are as follows.
观测结果如下。-很明显,这里的observation应该是观测结果,而非得出的结论。
3)我们不明白为何检测液色谱图中的积分参数改变了。因为按照美国药典的方法不能将该峰分离成两个可接受的基线峰,工作人员通过减小峰的视觉高度(用手动积分的方法)将该峰强制标记为两个低于1%的单峰。
by using the USP method修饰的是the peak can not be separated individually in two, acceptable baseline peaks,而不是they forcebly ( By manual integration ) marked it in two peaks;
by minimising the height visuality是手段而不是目的。
5)Lim=NMT 3.5%:limit=not more than 3.5%:限度:不超过3.5%
if at the time of release we will pass the material less than 97% purity如果药品药品在放行时的纯度低于97%
注意purity是指纯度而非杂质
So again the matter remains unanswered whether to release these materials taking in to account the calculated Risks in future or Reject these to avoid the Risks of inviting the impurities in our products.
因此,对这些原料到底是考虑到预计风险而放行还是拒绝放行以避免在我们的产品中产生杂质,这个问题依然悬而未决。
the matter指的是whether to……后面整句话。