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Nov 13, 2022 12:36
1 yr ago
68 viewers *
German term

können nicht Vorhandensein

German to English Medical Medical: Pharmaceuticals Certificate of Analysis
Phrase from an amino acid analysis certificate:

"Rückstände von Metallkatalysatoren oder Metallreagenzien gem. EMEA/CHMP/SWP/4446/2000 können nicht Vorhandensein."
Proposed translations (English)
4 +2 are not likely to be present
4 +4 no residues may be present
4 no residues allowed/ ensure there are no residues
References
"not likely to be present"

Discussion

Wolfskin (asker) Nov 15, 2022:
Dear colleagues, thank you for your help!
Hark Lüders Nov 14, 2022:
Right, should definitely read "vorhanden sein" - the noun doesn't make sense here. So this would translate as "Residues (...) might not be present", which is a bit weird, because it sounds like it would be preferable to have those residues. Makes me wonder if the "können" isn't a mistake, too. Maybe it should be "sollten" or "dürfen" (which is often synonymous with "können", but not in this context!)? Then we'd get "There ought to be no residues (...)"
philgoddard Nov 13, 2022:
"Vorhandensein" is a mistake - it should be "vorhanden sein". But I'm not sure about "können".

Proposed translations

+2
55 mins
Selected

are not likely to be present


Residues of metal catalysts or metal reagents according to EMEA/CHMP/SWP/4446/2000 are not likely to be present.

https://www.google.com/url?esrc=s&q=&rct=j&sa=U&url=https://...

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Note added at 58 mins (2022-11-13 13:35:41 GMT)
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https://www.google.com/url?esrc=s&q=&rct=j&sa=U&url=http://w...

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Note added at 1 hr (2022-11-13 13:40:57 GMT)
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Metal catalysts or metal reagents residues
􀁺 Not used: not used at all, or used during SM production and
„not likely to be present" (residues consistently removed, i.e.,
residues found below 30% of limits given in the guideline)

https://www.google.com/url?esrc=s&q=&rct=j&sa=U&url=https://...

--------------------------------------------------
Note added at 2 hrs (2022-11-13 15:19:01 GMT)
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I understand the German "können nicht vorhanden sein" as "metal residues may be present or may not be present". However, I agree, the German is a bit ambiguous, but I think that the English wording, as given in my examples above, is reliable.
Peer comment(s):
neutral philgoddard : This is possible, but can you explain the choice of "können"?// But if it means "may or may not be present", that's not the same as "are unlikely to be present".
24 mins
Thank you Phil. You are right the spelling should be 'vorhanden sein'. Please see also my last note above.
agree Anne Schulz : agree with "not likely to be present" (with CL = 1, for lack of precise context)
10 hrs
Thank you, Anne!
agree Johanna Timm, PhD : see the references I posted below:-)
1 day 4 hrs
Thank you, Johanna - also for the additional reference entries below.
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Thank you, Marga!"
+4
50 mins
German term (edited): Rückstände können nicht vorhanden sein

no residues may be present

This is a prohibition:
EMEA/CHMP/SWP/4446/2000 states that no residues of metal catalysts or metal reagents may be present.

The full wording of EMEA/CHMP/SWP/4446/2000 can be found here:
https://www.ema.europa.eu/en/documents/scientific-guideline/...
Peer comment(s):
neutral philgoddard : I'm not sure. Could "können" be an error, do you think, just as "can" is often misused in English? Shouldn't it be "müssen" or "dürfen"?
4 mins
Thanks. "dürfen nicht" would definitely work here. "müssen nicht vorhanden sein" = are not necessarily present
agree Lirka
6 hrs
agree Adrian MM. : https://ivowen.com/ich-elemental-imps/
9 hrs
agree Isabelle Villancher
1 day 43 mins
agree James Thurman : Agree. This sounds like a guideline imposing limits on the residues left over from a process
1 day 21 hrs
neutral Cilian O'Tuama : Visiting this quite late, all very dubious IMO - must not be, might not be. And "may" is also dubious. ST should be clearer. Grüße übrigens :-).
4 days
Once Dr T shows up, it's game over.
Something went wrong...
21 hrs

no residues allowed/ ensure there are no residues

"No residues of metal catalysts or metal reagents according to EMEA/CHMP/SWP/4446/2000 are allowed."
Note from asker:
Thank you, Cillie!
Something went wrong...

Reference comments

1 day 5 hrs
Reference:

"not likely to be present"

„können nicht vorhanden sein“= sind möglicherweise nicht vorhanden (abwesend) = „not likely to be present“ (absent)

Compare:
Staphylococcus aureus (abwesend in 1 g) entspricht
Candida albicans (abwesend in 1 g) entspricht
Salmonella ssp (abwesend in 10 g) entspricht
Rückstande von Metallkatalysatoren oder Metallreagenzien gem . EMEA/CHMP/SWP/4446/2000 können nicht vorhanden sein. Entspricht PhEur,USP,JPE
http://www.merckmillipore.com/INTERSHOP/web/WFS/Merck-CH-Sit...

English version:
Staphylococcus aureus (absent in 1 g) conforms
Candida albicans (absent in 1 g) conforms
Salmonella (absent in 10 g) conforms
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
'Value measured in qualified external laboratory
Corresponds to Ph Eur,USP,JPE
See the “Specification sheet” here:
https://www.sigmaaldrich.com/CA/en/product/mm/141354?gclid=C...
Note from asker:
Thank you, Johanna!
Peer comments on this reference comment:
neutral Cilian O'Tuama : It's possible that they are not present, i.e. they might not be present. "Not likely" means sth. else. Just languagewise IMO..
3 days 10 hrs
Something went wrong...
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