I'm working with a peptide comprised of 9 amino acids. A method has been validated for assaying the active component. While assaying the active, greater than 10 impurity/degradation peaks are observed. I have reference standards for 5 of the impurities and their concentration would be in units of mg/mL. The standard for the active component is in activity units/mL and I have no way of converting the units/mL to mg/mL. I need to validate an impurity/degradant assay complete with linearity, accuracy, and LOD and LOQ studies. If the standard for the active cannot be converted into mg/mL and not all of the impurity/degradant standards are known - - any suggestions on how to go about quantitating the impurities/degradants and validating a method???
Lynn
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