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aqms

木虫 (正式写手)


[交流] 求助USP Grade的确切翻译是什么?

USP Grade,是美国药典级,即列入美国药典的标准品或试剂,这是网上的翻译,但是我想知道的是,符合美国药典的普通药用试剂是否也可以标注USP Grade,还是专指美国的对照品?
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aqms(金币+3): 2011-02-16 15:33:24
不是符合美国药典标准的药都可以称之为“USP grade ”。

When you buy USP grade you are assured of 3 things:

1. The product was made to the exact specifications listed in it’s USP monograph
2. The manufacturer is FDA registered and licensed and the product HAS been approved(including the labeling/marketing material) by the FDA as meeting USP specifications.
3. The product was made in a FDA certified facility using cGMP(current good manufacturing practices) which are stringent to ensure lot to lot consistency.
3楼2011-02-15 13:07:44
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liwhite

铁杆木虫 (著名写手)


aqms(金币+1): 2011-02-16 15:33:31
USP Grade就是美国药典级,符合美国药典标准的普通试剂也应该是可以这么标注的。
2楼2011-02-15 13:04:18
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aqms(金币+1, 博学EPI+1): 2011-02-16 15:33:11
也就是说,标有这个标准的药至少满足三个条件:
1,它符合美国药典的要求;
2,它的制造商在FDA注册过且被授权生产该产品;
3,。。。。。。
4楼2011-02-15 13:09:24
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