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Koehler RC, Traystman RJ, Cooper AJL

Zimmerman, A

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Common quality-control elements include: Chromatographic purity by HPLC or an equivalent validated chromatographic method Identity confirmation by mass spectrometry Where available, net peptide content or quantitative assay information Analytical method validation principles for identity, purity, specificity, accuracy, precision, and related parameters are addressed in ICH Q2(R2), while FDA guidance on analytical procedures and method validation emphasizes that analytical procedures should be suitable for their intended purpose