主题:【每日一句(段)有奖翻译】<三十八> Monograph Components(13)

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影子
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不好意思,有几天没坚持了,现在再继续:

这个是关于残留溶剂的一个通则,不管专论中有没有规定,必须根据自己的工艺确定残留溶剂的标准并进行检测。

Residual Solvents in USP and NF Articles


1. All USP and NF articles are subject to relevant control of residual solvents, even when no test is
specified in the individual monograph.


2. If solvents are used during production, they must be of suitable quality.

3. In addition, the toxicity and residual level of each solvent shall be taken into consideration, and the
solvents limited according to the principles defined and the requirements specified in Residual
Solvents <467>, using the general methods presented therein or other suitable methods.
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2. If solvents are used during production, they must be of suitable quality.
如果在生产中使用溶剂,那么它们一定要具有合格的质量
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1. All USP and NF articles are subject to relevant control of residual solvents, even when no test is specified in the individual monograph.

所有的USP和NF法规受支配于残留溶剂的严格控制,即使在个别专论中没有具体的检测
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2011/3/2 17:21:06 Last edit by mitchell_dyzy
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3. 另外,每种溶剂的毒性和残余程度需要认真考量,按照药典规定和"残余溶剂”第467条专门要求的限用溶剂,要用相关内容给出的一般方法或者其它适用方法评价。
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poorlittle
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原文由 天黑请闭眼(shxie) 发表:
3. 另外,每种溶剂的毒性和残余程度需要认真考量,按照药典规定和"残余溶剂”第467条专门要求的限用溶剂,要用相关内容给出的一般方法或者其它适用方法评价。


Suggestion : 467"残余溶剂

= = = = = =

Is it possible that "In addition, the toxicity and residual level of each solvent shall be taken into consideration, and the solvents (shall be ???) limited according to the principles defined and the requirements specified in Residual Solvents <467>, using the general methods presented therein or other suitable methods."



If it is read as “the solvents shall be limited”, my interpretation would be :

并根据A及应用B来规限溶剂.

Where

A = [(the principles defined) and (the requirements specified)] in Residual Solvents <467>

B = the general methods presented therein or other suitable methods
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2011/3/7 14:59:43 Last edit by poorlittle
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原文由 poorlittle(poorlittle) 发表:
原文由 天黑请闭眼(shxie) 发表:
3. 另外,每种溶剂的毒性和残余程度需要认真考量,按照药典规定和"残余溶剂”第467条专门要求的限用溶剂,要用相关内容给出的一般方法或者其它适用方法评价。


Suggestion : 467"残余溶剂

= = = = = =

Is it possible that "In addition, the toxicity and residual level of each solvent shall be taken into consideration, and the solvents (shall be ???) limited according to the principles defined and the requirements specified in Residual Solvents <467>, using the general methods presented therein or other suitable methods."



If it is read as “the solvents shall be limited”, my interpretation would be :

并根据A及应用B来规限溶剂.

Where

A = [(the principles defined) and (the requirements specified)] in Residual Solvents <467>

B = the general methods presented therein or other suitable methods

您的解答方式很得体,受教了。
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