RE: Ph.Eur Monograph of Enalapril Maleate Contribution from Sophia written on 7/10/2008 at 05:35
Original contribution: Ph.Eur Monograph of Enalapril Maleate written by Deepan Pandya on 7/9/2008 at 19:01) EDQM take the identification as the CEP applicant's responsibility. So, you have to establish the impurity profile of your product. The impurities shall be identified in an appropriate way, such as purchase the impurities reference standard from chemical suppliers, or synthesize them in-house. Sure adequate characterization work shall be completed before use for the latter case
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