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which guideline is commonly referred to for method
Question:
Which guideline is commonly referred to for method validation in pharmaceutical analysis?
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ICH Q2 (R1) is the go-to guideline for validating analytical methods in pharmaceutical settings.
AP PGECET - 2025
AP PGECET
Updated On:
Jun 16, 2025
ICH Q3A
ICH Q2 (R1)
ICH Q1B
ICH Q4A
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The Correct Option is
B
Solution and Explanation
The ICH Q2 (R1) guideline is the internationally accepted standard for method validation in pharmaceutical analysis. It outlines parameters such as accuracy, precision, specificity, detection limit, quantitation limit, linearity, and robustness.
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