何倍保証

English translation: Explain what dilution of the Endotoxin limit is guaranteed

12:56 Nov 9, 2009
Japanese to English translations [PRO]
Medical - Medical: Pharmaceuticals / Standard values
Japanese term or phrase: 何倍保証
「規格及び試験方法」
エンドトキシン:規格値は何倍保証であるのか説明して下さい。

From a request for more information in a drug application.
何倍保証 is a bit baffling. Is the gist something like 'how many times has the standard value been confirmed in tests'. Is there perhaps some specific term like 'X-fold assurance'?
Steven Smith
United Kingdom
Local time: 20:25
English translation:Explain what dilution of the Endotoxin limit is guaranteed
Explanation:
I think this is two terms. 何倍保証 should be split up. I beleive it means something like: Endotoxin: Explain what multiple of the endotoxin content you guarantee that the standard is. In other words, there is a value for endotoxin content, and there is an endotoxin limit (EL) for it. The amount contained is less than the EL by several orders of magnitude. How many orders of magnitude or what mutliple of that can you guarantee? In other words, the 規格値 IS the multiple of the endotoxin content. A helpful word for research might be "dilution." I'm not sure about any of this, but I think it's on the right track.

See page 148 in the first ref. The sample sentence is from the second ref.
Selected response from:

Michael Karpa
United States
Local time: 12:25
Grading comment
Thanks. Still not entirely sure of the meaning, but your answer enabled me to give the client some intelligent suggestions.
4 KudoZ points were awarded for this answer



Summary of answers provided
2Explain what dilution of the Endotoxin limit is guaranteed
Michael Karpa


  

Answers


2 hrs   confidence: Answerer confidence 2/5Answerer confidence 2/5
Explain what dilution of the Endotoxin limit is guaranteed


Explanation:
I think this is two terms. 何倍保証 should be split up. I beleive it means something like: Endotoxin: Explain what multiple of the endotoxin content you guarantee that the standard is. In other words, there is a value for endotoxin content, and there is an endotoxin limit (EL) for it. The amount contained is less than the EL by several orders of magnitude. How many orders of magnitude or what mutliple of that can you guarantee? In other words, the 規格値 IS the multiple of the endotoxin content. A helpful word for research might be "dilution." I'm not sure about any of this, but I think it's on the right track.

See page 148 in the first ref. The sample sentence is from the second ref.

Example sentence(s):
  • To test with a safety factor that is double or five times more sensitive than the EL (endotoxin limit)...

    Reference: http://books.google.com/books?id=kAajPoqnbH4C&pg=PA148&lpg=P...
    Reference: http://www.criver.com/SiteCollectionDocuments/qc_mm_n_endosa...
Michael Karpa
United States
Local time: 12:25
Works in field
Native speaker of: English
PRO pts in category: 8
Grading comment
Thanks. Still not entirely sure of the meaning, but your answer enabled me to give the client some intelligent suggestions.
Notes to answerer
Asker: Thanks. That's extremely helpful.

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