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haowenjing银虫 (正式写手)
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[求助]
求英语牛人帮忙翻译一下
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| The manufacture of the active substance was satisfactorily described including a flow chart. Empagliflozin is synthesized from well-defined starting materials with acceptable specifications. Enough of the manufacturing process is described and the physicochemical properties of the active substance are well controlled by the process. Potential and actual impurities were well discussed with regards to their origin and fate and characterised. The characterisation of the active substance and its impurities are in accordance with the EU guideline on chemistry of new active substances. |
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