Glossary entry

Spanish term or phrase:

Requerimientos de adecuación del sistema

English translation:

system suitability requirements/parameters/specifications

Added to glossary by liz askew
Feb 14, 2016 21:38
8 yrs ago
7 viewers *
Spanish term

Requerimientos de adecuación del sistema

Spanish to English Medical Medical: Pharmaceuticals trabajo práctico faculta
Requerimientos de adecuación del sistema: el factor de tailing para el pico del analito es menor de 2.5, el factor de resolución entre los picos de las drogas es mayor de 4, y el coeficiente de variación porcentual para inyecciones replicadas es menor de 2,0 %.

Requirements for system adjustment: the tailing factor for the analyte peak is less than 2.5, the resolution factor between the drugs peak is higher than 4 and the coefficient of variation for replicate injections is not more than 2.0%.
Change log

Feb 16, 2016 10:51: liz askew changed "Edited KOG entry" from "<a href="/profile/1958834">sebaspedlp's</a> old entry - "Requerimientos de adecuación del sistema"" to ""system suitability requirements/parameters/specifications""

Proposed translations

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Selected

system suitability requirements/parameters/specifications

Hello,
Pharmaceuticals is not my field at all, but should these suggestions help, then good luck with your work!

Saludos!

<621> CHROMATOGRAPHY - SYSTEM SUITABILITY - u.s. ...
www.pharmacopeia.cn/v29240/usp29nf24s0_c621s12.html
System suitability tests are an integral part of gas and liquid chromatographic methods. ... Column efficiency may be specified also as a system suitability requirement, ... The tailing factor, T, a measure of peak symmetry, is unity for perfectly ...
calculation of System Suitability in Chromatography
lab-training.com › Chromatography
27 Feb 2013 - The current post introduces you to system suitability parameters and their ... Tailing becomes apparent when asymmetry factor As equals to or ...
[PDF]〈621〉 CHROMATOGRAPHY
https://hmc.usp.org/sites/default/files/documents/HMC/GCs......
common parameters and describes general requirements for the mobile phase to ..... covered in the System Suitability section of this chapter. layer with the .... known as the tailing factor) of a peak (see Figure 4) is calcu-. For the Assay in a ...
[PDF]Evaluating System Suitability - Agilent Technologies
https://www.agilent.com/cs/library/Support/Documents/a10424....
246. Evaluating System. Suitability. Evaluating the performance of both the ... tailing. Laboratories which have to comply with: • Good Laboratory Practice regulations (GLP),. • Good Manufacturing Practice regulations (GMP) and Current Good.
[PDF]Reviewer Guidance - Food and Drug Administration
www.fda.gov/downloads/Drugs/.../Guidances/UCM134409.pdf
PARAMETERS FOR VALIDATION OF HPL CHROMATOGRAPHIC. METHODS ... System Suitability Specifications and Tests ..................... 21. 1 . ... Tailing factor .
Note from asker:
Thank you so much Liz!!
Peer comment(s):

agree Charles Davis
7 mins
Thank you for your support!
agree José Julián Díaz
1 hr
Thank you for your support!
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4 KudoZ points awarded for this answer. Comment: "thank you!"
1 hr

System standardisation

It's about bringing criteria into line; 'requirements' seems superfluous to me here.
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