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10.1016/j.molmed.2006.09.007 117 WuY.HuH.HuJ.LiuS

S., Armutcu, F., Sahin, S

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What a Meaningful Epithalon Certificate of Analysis Should Include Complete Epitalon or Epithalon name Full Ala-Glu-Asp-Gly sequence Single-letter AEDG sequence Confirmation of N and C terminal groups Declared free-peptide or acetate form Observed intact molecular mass Tandem-MS sequence evidence Quantitative net peptide assay Chromatographic purity Named and unknown related-substance results Acetate result where applicable Water-content result Residual-solvent results Elemental-impurity results where appropriate Aggregate or higher-molecular-weight-species assessment Finished-product stability information Finished-product batch number Testing-laboratory identity Analytical methods and acceptance criteria A clear statement of tests not performed Why 99% HPLC Is Not Enough A single chromatographic percentage does not prove that the main peak contains AEDG in the correct residue order