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19:11 Jun 29, 2016 |
Spanish to English translations [PRO] Medical - Medical: Pharmaceuticals / Eye drops - Degradation products | |||||||
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| Selected response from: Biomed Sci Local time: 03:57 | ||||||
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Summary of answers provided | ||||
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4 | Individual unknown impurities |
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Discussion entries: 1 | |
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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 |
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