Individuales desconocidos

English translation: Individual unknown impurities

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:Individuales desconocidos
English translation:Individual unknown impurities
Entered by: Lorna O'Donoghue

19:11 Jun 29, 2016
Spanish to English translations [PRO]
Medical - Medical: Pharmaceuticals / Eye drops - Degradation products
Spanish term or phrase: Individuales desconocidos
Productos de degradación
Totales
Impureza A
Impureza B
Impureza G
Individuales desconocidos
≤ 0,7%
≤ 0,3%
≤ 0,3%
≤ 0,15 %
≤ 0,1%
Método Interno
Esterilidad

Maybe someone with experience translating pharmaceutical texts can help with this? TIA
Lorna O'Donoghue
Local time: 02:57
Individual unknown impurities
Explanation:
The impurities in pharmaceuticals are unwanted chemicals that with the APIs or develop during formulation or upon ageing of both API and formulation.
[1] The presence of unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product.
An unknown impurity will not correspond to any known peaks on, for example, HPLC analysis

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Note added at 1 hr (2016-06-29 20:14:42 GMT)
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P.S. I've also seen "unidentified" and "unspecified" used, although perhaps not as frequently.
Selected response from:

Biomed Sci
Local time: 03:57
Grading comment
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4Individual unknown impurities
Biomed Sci


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46 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
Individual unknown impurities


Explanation:
The impurities in pharmaceuticals are unwanted chemicals that with the APIs or develop during formulation or upon ageing of both API and formulation.
[1] The presence of unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product.
An unknown impurity will not correspond to any known peaks on, for example, HPLC analysis

--------------------------------------------------
Note added at 1 hr (2016-06-29 20:14:42 GMT)
--------------------------------------------------

P.S. I've also seen "unidentified" and "unspecified" used, although perhaps not as frequently.


    Reference: http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...
    https://books.google.es/books?id=x68XDAAAQBAJ&pg=PA339&lpg=PA339&dq=%22individual+unknown+impurities%22&source=bl&ots=IxLjCyfzet&sig=cJpGryq
Biomed Sci
Local time: 03:57
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 16
Grading comment
Thanks for your help.
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