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ICH Q2(R2) also notes that representative data such as chromatograms can help demonstrate specificity for assay, purity, or impurity tests [13]
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doi: 10.1002/jcp.24666 109 LiuJZhangXChengYCaoX
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Ask the seller whether any required step remains incomplete. Confirm the actual recorded outcome against the agreed resolution.
Describe what you expected and what remains unclear. If the stated response period passes, follow the seller's published follow-up route.
Look at any explanation placed near the qualified claim. Check whether different versions have different limits or starting values.
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