Setting up specifications
Analysis of residual solvents in pharmaceuticals

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P3260 V2 Article

Setting up specifications


Analysis of residual solvents in pharmaceuticals

Authors : Michel BAUER, Gwenola BURGOT

Publication date: March 10, 2020 | Lire en français

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3. Setting up specifications

3.1 ICH objectives

In the paragraph 1 , it was pointed out why residual solvents should be identified and dosed in pharmaceutical products:

  • potential toxicity ;

  • consequences on...

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