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Certificate of Analysis of Ibufron  Form

Certificate of Analysis of Ibufron Form

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Instructions and help about Certificate Of Analysis Of Ibufron

welcome to this webinar entitled certificate of analysis essentials for regulated bioanalysis during the course of this webinar we will address the following questions what is a reference standard and why use one is a given reference standard appropriate for its intended use what data does a reference standard certificate of analysis contain how to interpret data from a certificate of analysis and we will also address the case of large molecules biotherapeutics and peptides now let's start with definition and purpose a reference standard or reference material is a substance prepared for use as the standard in an assay identification or purity test it should have a quality appropriate to its use for example for new molecular entities a reference standard provided by the study sponsor can be appropriate for pre-clinical studies the quality and level of characterization of a reference standard depends on the stage of drug development for example at discovery stage a reference standard may

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