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  3. Chemistry; Chem Sci/Eng

Leachables

16:24 Apr 13, 2012
English language (monolingual) [PRO]
Chemistry; Chem Sci/Eng / Фармацевтика.
English term or phrase: Leachables
Leachables, Volatile and Semi-Volatile Organic compounds from Container/Closure System.
ICH requires the determination of the level of extractables and leachables from containers and closure systems. Development and stability data should demonstrate that extractables from container/closure systems are consistently below levels that are acceptable and safe. The company has developed in-house validated methods for the analysis of plasticisers and leachables from rubber seals, tubing and containers as well as analysis methods for other extractables.
Наталья


SUMMARY OF ALL EXPLANATIONS PROVIDED
4 +3compounds leaching from elastomeric plastic compounds of containers
Jack Doughty
4lixiviáveis
Martin Riordan


  

Answers


10 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
leachables
lixiviáveis


Explanation:
Veja a pergunta no Kudoz no link abaixo.


    Reference: http://www.proz.com/kudoz/english_to_portuguese/medical%3A_c...
Martin Riordan
Brazil
Local time: 15:48
Native speaker of: Native in EnglishEnglish
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)
neutral  Colin Rowe: What makes you think the asker understands Portuguese?
8 mins
  -> Oh Colin, it's that dicky digit again and a lack of attention! Thank you for your comment...
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The asker has declined this answer

17 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
leachables
compounds leaching from elastomeric plastic compounds of containers


Explanation:
Leachables are defined as “compounds that leach from elastomeric, plastic compounds or coatings of the container & closure system as a result of direct contact with the formulation during the shelf-life of the product.”
http://www.rapra.net/consultancy/chemical-analysis-leachable...

Jack Doughty
United Kingdom
Local time: 19:48
Native speaker of: English
PRO pts in category: 60
Notes to answerer
Asker: Thank you very much! Your answer is brilliant!


Peer comments on this answer (and responses from the answerer)
agree  Colin Rowe: Comprehensive answer.
2 mins
  -> Thank you.
agree  B D Finch: Though I believe that "compounds that can leach from ..." might be more accurate, i.e. the leaching might not (yet) be occurring.
7 mins
  -> Thank you. You're probably right.
agree  Phong Le
8 days
  -> Thank you.
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The asker has declined this answer



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