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Analytical Method Validation (ICH Q2(R1)) All quantitative analytical methods used for tirzepatide release, stability, and impurity testing must be validated per ICH Q2(R1) (Method Validation) to demonstrate: specificity (absence of interference from related substances and matrix components)

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It is crucial to avoid this medication if there is a personal or familial history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2