NOVEX NOTES 193 / English
Reporting thresholds in impurity analysis
Editorial educational material · 16 October 2026
Understanding the question
A report may use defined rules for which findings are listed. An omitted signal and a demonstrated absence are different statements. The reader needs the reporting basis and the scope of the test.
A worked example
In a fictional summary, small findings are not shown in the final table. The reviewer asks whether they were below a documented reporting rule or not evaluated at all. The answer changes what the summary supports, even if the visible table looks equally clean in both cases.
Original editorial teaching example, not clinical trial findings.What to check
Read the method, threshold and definitions. Do not interpret a blank field as zero or apply a threshold from one impurity assessment to another without a justified basis.
Source and further reading
EMA — ICH Q3C Residual solvents ↗
Educational material. The source concerns the scientific topic, not NOVEX products. This article does not verify product properties or provide administration instructions. A short guide is not a systematic review.