Glossary entry

English term or phrase:

extractables and leachables

Romanian translation:

substanţe extractibile şi produse de degradare

Added to glossary by Irina Zbravoz
Oct 5, 2011 19:32
12 yrs ago
10 viewers *
English term

extractables and leachables

English to Romanian Medical Medical: Pharmaceuticals biopharmacy
extractables and leachables testing
Change log

Oct 6, 2011 06:21: George C. changed "Level" from "Non-PRO" to "PRO"

Votes to reclassify question as PRO/non-PRO:

PRO (3): Sandra & Kenneth Grossman, Claudia Coja, George C.

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Proposed translations

+1
2 hrs
Selected

substanţe extractibile şi produse de degradare

Proiectarea studiilor toxicocinetice pentru produse de degradare şi substanţe extractibile.
http://freelex.juridic.ro/DocumentView.aspx?DocumentId=73913
SR EN ISO 10993-16:2003
Evaluarea biologică a dispozitivelor medicale.
Partea 16: Proiectarea studiilor toxicocinetice pentru produse
de degradare şi substanţe extractibile
Înlocuit prin: SR EN ISO 10993-16:2009
http://www.asro.ro/romana/publicatii/Buletin 2010/Buletin Ma...
Note from asker:
exact pentru SGS trebuia sa traducș eu gasisem si termenul "lixiviabil", insa nu eram sigura.
Peer comment(s):

agree George C.
7 hrs
Multumesc:)
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "multumesc Claudia!"

Reference comments

2 hrs
Reference:

extractables and leachables

􀂄 Extractable: Any chemical species that can be
removed from a packaging component under abusive
laboratory conditions
􀂄 Leachable: an extractable that actually migrates into a
drug product under storage conditions
http://www.us.sgs.com/cvg100506.pdf
Peer comments on this reference comment:

agree Cristina Crişan : Cred că se traduc ambele prin extractibile -Toxicokinetic study design for degradation products and leachables http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2...
10 hrs
Something went wrong...
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