求助各位大侠，谁能帮帮忙翻译一下美国药典的可见异物检查法，万分感谢！

下面的网址有你要的美国药典原文PARTICULATE MATTER IN INJECTIONS
http://127.0.0.1:29240/uspnf/pub/index?usp=29&nf=24&s=0
可以在这个网址进一步查找相关内容，有什么不会翻译的可以提出来大家一起帮你看看，可不能全靠别人帮忙啊，毕竟学好专业英语对自己是很有帮助的。

好像看不了啊，谁有可见异物的各国药典对比啊

Visible particles (those greater than approximately 50 microns) in finished products are normally detected through visual inspection of the end-product by trained operators under controlled conditions. There are ongoing efforts to partially or completely automate this process and there is a Visible Particle Interest Group in the Parenteral Drug Association (or PDA).

In the sub-visible range (less than 50 microns), US Pharmacopeia (USP), European Pharmacopeia (EP) and Japanese Pharmacopeia (JP) specify the protocols, equipment and acceptable limits for particulate matter in injectables. The respective web sites and reference documents are www.usp.org Chapter 788, www.pheur.org General Notice 1 Section 2.9.19 and jpdb.nihs.go.jp/jp14e/ Chapter XIV Section 24. Presently there are separate standards however the requirements are being harmonized across all three jurisdictions.


There is one specific document that you need to read, USP <788>. The current version of USP is 30, it is released annually and is combined with the NF (United States Pharmacopoeia & National Formulary). Test 788 refers to particulate matter in injectables (this includes all injectables, SVP & LVP), the first part is that it must be free from all visible particles, these are deemed to be those that are above 100 um, and then set limits are imposed for sub visible particles, 10 & 25 um in size. We have an application note on our website that will point you in the right direction regarding numbers.

revisionGeneralChapter788

可见异物检查法
visible (particles) inspection

没有对比啊。