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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 lets 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 ma