the spike and purge study
Russian translation: испытание по вымыванию/удалению добавленных примесей
| 13:36 Mar 31, 2021 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals / Обоснование для спецификация | |||||||
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|  Selected response from: Natalie Poland Local time: 15:06 | ||||||
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| 5 | испытание по вымыванию/удалению добавленных примесей |
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| 2 | см. ссылки |
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Answers
6 hrs confidence: 
см. ссылки Explanation: В фармацевтике несильна, но возможно purge study - идет речь об очистке/ устранении примесей? Это отрывок из статьи ниже, посмотрите еще две другие ссылки, может будет полезно. A common method is “impurity fate mapping,” or “spike and purge testing,” to monitor the purging capability of a synthetic process. This testing involves spiking the impurity—for example, to a level of several thousand parts per million—where it occurs and then tracking it through the synthesis. Considerable time and effort are put into developing analytical methods to track impurities. https://cen.acs.org/articles/88/i39/Genotoxic-Impurities.htm... https://www.lhasalimited.org/Public/Library/2017/Drug%20Master%20File%20Holders%20Preferred%20PGI%20Control%20Strategy%20Under%20ICH%20M7.pd https://www.ema.europa.eu/en/documents/referral/assessment-report-article-53-procedure-gentamicin_en.pdf |
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1 day 2 hrs confidence:
испытание по вымыванию/удалению добавленных примесей Explanation: Spike означает добавление известного количества чего-то, в данном случае некоего вещества, являющегося примесью, а purge - соответственно, удаление этой добавки. Вот пример, из которого вполне понятно, о чем речь: In this case, the sponsor must demonstrate by a spike and purge study that impurity Y is purged out during the successive steps of the manufacturing process when present at the maximum acceptable limit... https://farmasiindustri.com/wp-content/uploads/2016/03/solid... |
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