Certified reference materials (CRMs) are the backbone of reliable mycotoxin analysis in accredited laboratories. Yet, until now, there has been no systematic, comparative evaluation of their real-world quality.
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30% of tested reference standards were outside the acceptable target value range when confirmed by both LC-MS/MS and HPLC-DAD
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Up to 50% deviated when results from either method were considered
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Multiple impurities were detected in all toxin groups using LC-HRMS (12 in DON, 10 in AFB1, 8 in ZON)
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Significant differences were observed in uncertainty reporting and stability performance across suppliers
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In one case, long-term instability led to a target value recovery of only ~80%
Key recommendations
Based on these findings, the paper proposes concrete improvements to ISO 17034 practices:
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Use q-NMR as a standardized method for raw material purity determination
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Harmonize uncertainty limits:
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≤ 3% for liquid standards with ≤1 year shelf life
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≤ 5% for longer shelf lives
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Implement continuous long-term stability monitoring
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Include HPLC and LC-MS/MS release data on Certificates of Analysis for each batch
Impact
These recommendations aim to improve transparency, comparability, and reliability of mycotoxin reference materials worldwide—ultimately strengthening food and feed safety, regulatory compliance, and laboratory confidence.
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