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REFERENCE [Guideline] US Food and Drug Administration

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A credible lab packet should include Therefore, exact amino-acid sequence and structural modifications Moreover, theoretical molecular mass and observed LC-MS mass As a result, lot-specific HPLC or UPLC purity data Likewise, measured peptide content per finished vial By contrast, counterion and water-content basis where relevant In addition, full chromatogram and mass spectrum However, batch traceability and verifiable laboratory identity For example, Name alone is not identity