ensaios limite

English translation: limit tests

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Portuguese term or phrase:	ensaios limite
English translation:	limit tests
Entered by:	ServingMed.com

08:38 Jun 2, 2016

Portuguese to English translations [PRO]
Medical - Medical (general) / drug and medication validation protocols

Portuguese term or phrase: ensaios limite

Dispõe sobre a validação de métodos analíticos de ensaios biológicos, microbiológicos, imunológicos, de identificação, quantitativos para a determinação de impurezas, ensaios limite para o controle de impurezas, ensaios quantitativos para a determinação de insumos farmacêuticos em amostras de matérias-primas ou de medicamentos em todas as suas fases de produção, e dá outras providências.

I can't find a specific reference to a limited trial or limit trial, or a limited or limit assay for impurities - might there be another term I'm missing?

Thanks in advance,

Juliette

ServingMed.com KudoZ activity Questions: 380 (5 open) (9 without valid answers) (16 closed without grading) Answers: 4 Netherlands
Local time: 07:36

limit tests

Explanation:
limit tests (for control of impurities)

http://www.pharmaguideline.com/2011/07/limit-tests.html

http://www.web-formulas.com/Formulas_of_Chemistry/Definition...

http://community.learnaboutgmp.com/t/analytical-method-valid...

Hope it helps,
EjR

Selected response from:

Eduardo Ramos
Thailand
Local time: 12:36

Grading comment

Gracias!
4 KudoZ points were awarded for this answer

Summary of answers provided

4 +7

limit tests

Eduardo Ramos

Limit tests

J_Ricardo

Discussion entries: 3

Answers

18 mins confidence:

peer agreement (net): +7

limit tests

Eduardo Ramos
Thailand
Local time: 12:36
Works in field
Native speaker of:

Portuguese,

English
PRO pts in category: 8

Grading comment

Gracias!

17 hrs confidence:

Limit tests

Explanation:
Types of Analytical Procedures to be Validated
The discussion of the validation of analytical procedures is directed to the four
most common types of analytical procedures:
- Identification tests;
- Quantitative tests for impurities' content;
- Limit tests for the control of impurities;
- Quantitative tests of the active moiety in samples of drug substance or drug
product or other selected component(s) in the drug product.

Reference: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Gu...

J_Ricardo
Brazil
Local time: 02:36
Works in field
Native speaker of:

Portuguese

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