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News專家顧問 (職業(yè)作家)
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[求助]
EP對照品純度問題
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我們買了兩種EP對照品,結(jié)果瓶子和對照品文件上面未標(biāo)明對照品的純度,詢問代理商,他們也不知道。不知道有木有蟲友碰到過這種狀況呢?你們是怎么解決的? 如果,有文獻(xiàn)資料請上傳文獻(xiàn)資料, |
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專家顧問 (職業(yè)作家)

捐助貴賓 (著名寫手)
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http://www.edqm.eu/en/EDQM-FAQ-a ... 0.html?rubrique=468 01. How can I find out the purity of a Ph. Eur. CRS? The assigned content of a CRS is given in the online search catalogue and on the CRS label, when it is required to calculate the content using the prescribed test and/or assay of a prevailing European Pharmacopoeia monograph. In other cases, values are not assigned and it cannot be assumed that the purity is 100%. However, the purity of an impurity CRS, can be assumed to be 100% for the test for related substances of the prevailing European Pharmacopoeia monograph, if the purity is not indicated. The assigned content of lyophilised preparations may be expressed as mass of pure substance per vial (eg mg/vial) or potency per vial (eg IU units/vial). |
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