Questions tagged [methodvalidation]
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Why Assuming RRF = 1.0 Risks Toxic Impurity Errors
In HPLC analysis, the biggest lie a chromatogram can tell you is that "bigger peak = more amount." We all know that different molecules i...
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Carryover – The Hidden Threat to Analytical Accuracy
In analytical science, precision is non-negotiable. Yet, one silent contaminant can distort results and jeopardize data integrity — carryover. Wh...
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Why Spike Impurities Below LOQ in Method Validation (Related Substances – Accuracy Studies)?
During HPLC method validation for related substances, spiking impurities at levels below the LOQ may seem unnecessary—since values below LOQ are “...
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Essential for Every Analyst: Mastering Method Validation According to #ICHQ2 Guidelines!
Method validation is fundamental for ensuring the accuracy, reliability, and regulatory compliance of analytical data in pharmaceuticals, #QualityCont...